Skip to main content

AD: Shocked! The peak value of plasma Aβ42/Aβ40 began to decline 41 years before the deposition of brain Aβ!

 AD: Shocked! The peak value of plasma Aβ42/Aβ40 began to decline 41 years before the deposition of brain Aβ! Alzheimer's diseases: New discovery on plasma Aβ42/Aβ40.  AD: Shocked! The peak value of plasma Aβ42/Aβ40 began to decline 41 years before the deposition of brain Aβ! Amyloid β (Aβ) plaque deposition and phosphorylated tau (p-tau) protein tangles are two important pathological features of Alzheimer's disease (AD), and there are many kinds of AD biomarkers derived around them, Knowledge of the longitudinal trajectories of key markers could not only help improve the selection and monitoring of participants in clinical trials, but also help identify those at high risk for neurodegenerative changes and cognitive impairment.   Although research on AD biomarkers has increased substantially in recent years, research on longitudinal changes in biomarkers is relatively limited. Studies have shown that the levels of plasma Aβ 42 /Aβ 40 , p-tau181 and glial fibrillary acidic...

COVID-19: Chinese Reagent Test kits with Certificates

COVID-19: Chinese Reagent Test kits with Certificates


CCCMHPIE  updated the list on March 23 2021, which listed the Chinese companies that have obtained the certificate issued by other countries for Coronavirus Reagent Test kit. 





Name List of Coronavirus Reagent Test kits Companies with Certification/Authorization from other Countries:



1

北京万泰生物药业股份有限公司
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

91110114600067778R

CE

Wantai SARS-CoV-2 RT-PCR Kit(REF:WS-1248)
Wantai SARS-CoV-2 Ab ELISA(REF:WS-1096)
Wantai SARS-CoV-2 IgM ELISA(REF:WS-1196)
Wantai SARS-CoV-2 Ab Rapid Test (REF:WJ-2701,WJ-2710,WJ-2750)
WANTAI SARS-COV-2 Ag Rapid Test (FIA) - REF: WJ-2810, WJ-2850
Wantai SARS-CoV-2 Ag Rapid Test (Colloidal Gold) - REF: WJ-2910,WJ-2950
Wantai SARS-CoV-2 Ag ELISA – REF: WS-1496
Wantai SARS-CoV-2 IgG ELISA (Quantitative) – REF: WS-1396
Wantai SARS-CoV-2 IgG Rapid Test (Semi-Quantitative) – REF: WJ-3010, WJ-3050

2

深圳市锦瑞生物科技有限公司
Genrui Biotech Inc.

91440300766350741W

CE

Novel Coronavirus（2019-nCoV）IgG/IgM Test Kit (Colloidal gold)
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

3

安徽福贸生物科技有限公司
Anhui Formaster Biosci Co., Ltd.

91340225MA2TENM49Y

CE

New Coronavirus(COVID-19)IgG/IgM Rapid Test Device
New Coronavirus (COVID-19) Antigen Rapid Test
Influenza A&B/COVID-19 Antigen Combo Rapid Test
COVID-19 Neutralizing Antibody Rapid Test
New Coronavirus (COVID-19) Antigen Rapid Test (saliva) 

4

安徽深蓝医疗科技股份有限公司
Anhui Deepblue Medical Technology Co., Ltd.

913401005501903714

CE

COVID-19(SARS-CoV-2) Antibody Test Kit(Colloidal Gold)
COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
COVID-19 (SARS-CoV-2) Antibody & Antigen   Combo Test Kit (Colloidal Gold)

5

必欧瀚生物技术（合肥）有限公司
BIOHIT HealthCare(Hefei) Co., Ltd.

913401000822055000

CE

SARS-CoV-2 IgM/IgG antibody test kit(Colloidal Gold Method)
SARS-CoV-2 Antigen quantitative assay (enzyme-linked immunoassay)
SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)

6

北京金沃夫生物工程科技有限公司
Beijing Jinwofu Bioengineering Technology Co. Ltd.

911101067861530162

CE

Jinwofu® SARS-CoV-2 IgM/IgG Antibody Rapid Test(Jinwofu® Novel Coronavious(SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit)
Jinwofu® SARS-CoV-2 IgG Antibody Rapid Test(Jinwofu® Novel Coronavious(SARS-CoV-2) IgG Antibody Rapid Test Kit)
Jinwofu® SARS-CoV-2 IgM Antibody Rapid Test(Jinwofu® Novel Coronavious(SARS-CoV-2) IgM Antibody Rapid Test Kit)

7

北京科卫临床诊断试剂有限公司
Beijing Kewei Clinical Diagnostic Reagent  Inc.

911101161022068352

CE

COVID-19 IgG/IgM Antibody Rapid Test Kit,COVID-19 Antigen Rapid Test
Kit,COVID-19 IgG Antibody ELISA Test Kit,COVID-19 IgM Antibody ELISA
Test Kit,COVID-19 Antigen ELISA Test Kit

8

北京库尔科技有限公司
Core Technology Co., Ltd.

91110114785541383H

CE

COVID-19 IgM/IgG Ab Test
Model:strip 50 tests/kit,cassette 1 test/kit, 25 tests/kit, 40 tests/kit
COVID-19 Ag Test
COVID-19 Neutralizing Ab Test
COVID-19 Saliva Ag Test
Influenza A+B & COVID-19 Ag Combo Test

9

北京乐普诊断科技股份有限公司
Beijing Lepu Medical Technology Co., Ltd.

911101146705533929

CE

SARS-CoV-2 Antibody Test(colloidal gold immunochromatography) Model:20 tests per box
SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
2019-nCoV Neutralization Antibody Test Kit (Fluorescence Immunochromatography)
2019-nCoV Neutralization Antibody Test Kit (ELISA)
2019-nCoV Neutralization Antibody Test Kit (Colloudal Gold Immunochromatography)
2019-nCoV Neutralization Antibody 2nd Gen Rapid Test Kit (Colloudal Gold Immunochromatography)
2019-nCoV Antigen, Influenza A Virus Antigen, Influenza B Virus Antigen Detection Kit (Colloudal Gold Immunochromatography)

10

北京热景生物技术股份有限公司
Beijing Hotgen biotech Co., Ltd.

91110115777090586H

CE

Coronavirus disease(COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay)
Coronavirus disease(COVID-19) IgM/IgG Antibody Test (Enzyme-Linked Immunosorbent Assay)
Coronavirus disease( COVID-19) Nucleic Acid Test Kit(PCR-Fluorescent Probe Method)
Coronavirus disease( COVID-19) Antibody Test(Up-converting Phosphor Technology)
Coronavirus disease( COVID-19) IgM/IgG Antibody Test(Up-converting Phosphor Technology)
Coronavirus disease( COVID-19) IgM/IgG Antibody Rapid Test(Colloidal Gold)
Coronavirus disease(COVID-19) Antibody Test(Colloidal Gold)
CORA CHECK-19 Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)
Novel Coronavirus 2019-nCoV Antigen Test (Up-converting Phosphor Immunochromatographic Technology)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)
SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Competition Up-converting Phosphor Immunochromatographic Technology)
Novel Coronavirus (SARS-CoV-2) Antigen Test (Chemiluminescence Immunoassay)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Chemiluminescence Immunoassay)
Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)

11

厦门艾德生物医药科技股份有限公司
Amoy Diagnostics Co., Ltd.

9135020066474298XL

CE

AmoyDx® Novel Coronavirus(2019-nCoV) Detection Kit 24 tests/kit

12

厦门宝太生物科技有限公司
Xiamen Biotime Biotechnology Co., Ltd.

91350205671268681J

CE

SARS-CoV-2 IgG/IgM Rapid  test kit(Colloidal Gold Method)
SARS-CoV-2 IgG/IgM Rapid Qualitative Test
SARS-CoV-2  Antigen Rapid Qualitative Test

13

厦门为正生物科技股份有限公司
Xiamen Wiz Biotech Co., Ltd.

91350200072804016N

CE

Diagnostic Kit(Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 25 Tests/kit
SARS-CoV-2 Antigen Test
SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test

14

海格德生物科技（深圳）有限公司
H-Guard(China) Co., Ltd.

91440300077516830Q

CE

Novel Coronavirus COVID-19 IgM/IgG Test Kit(colloidal gold)
COVID-19 Antigen Test Kit (Lateral Chromatography)

15

珠海市银科医学工程股份有限公司
Zhuhai Encode Medical Engineering Co., Ltd.

91440400789435684P

CE

SARS-CoV-2 IgG/IgM Schnelltest
SARS-COV-2 Antigen Rapid Test Device

16

武汉明德生物科技股份有限公司
Wuhan EasyDiagnosis Biomedicine Co., Ltd.

9142010066953862X0

CE

COVID-19(SARS-CoV-2) IgM/IgG Antibody Test Kit
COVID-19 (SARS-CoV-2) Antigen Test Kit
COVID-19 (SARS-CoV-2) nucleic acid test kit
COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (Freeze-dried)
COVID-19 & Influenza A/B Nucleic Acid Test Kit

17

武汉生之源生物科技股份有限公司
Wuhan Life Origin Biotech Joint Stock Co., Ltd.

91420100698327549A

CE

SARS-CoV-2 IgM/IgG Antibody Assay Kit(Immunochromatography)
SARS-CoV-2 Nucleic Acid Dual-Detection Kit(Real-Time PCR Method)
The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)

18

光景生物科技（苏州）有限公司
Lumigenex(Suzhou) Co., Ltd.

91320594551169670K

CE

SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit(TRFIA);Product code:P09001,P09010,P09020,P09050
PocRoc® SARS-CoV-2 Antigen Rapid Test Kit

19

江苏硕世生物科技股份有限公司
Jiangsu Bioperfectus Technologies Co., Ltd.

91321291553790049X

CE

COVID-19 Coronavirus Real Time PCR Kit,Novel Corona Virus(SARS-CoV-2) Ag Rapid Test Kit,Novel  Corona Virus(SARS-CoV-2) IgM/IgG Rapid Test Kit(Corona Virus Test Kits)

20

苏州新波生物技术有限公司
Suzhou Sym-Bio Lifescience Co., Ltd.

913205857287201588

CE

COVID-19 Kit PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
SuperFlex Anti-SARS-CoV-2 Ab Kit
SuperFlex Anti-SARS-CoV-2 IgG Kit
SuperFlex Anti-SARS-CoV-2 IgM Kit
SuperFlex Trigger Solution
PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel

21

苏州海苗生物科技有限公司
HymonBio Co., Ltd.

91320585354528566E

CE

 Hymon TM SARS-COV-2 Test Kit

22

山东欣莱生物科技有限公司
Shandong ThinkLab Biotechnology Co., Ltd.

91370800MA3DCF8E6W

CE

2019-nCoV IgM&IgG antibody Test Kit(Colloidal-gold Assay)
Product Type:10T/Kit, 25T/Kit, 50T/Kit
Coronavirus Ag Rapid Test Cassette (Swab)

23

青岛汉唐生物科技有限公司
Qingdao Hightop Biotech Co., Ltd.

9137022269377952XM

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test
SARS-CoV-2 IgG Antibody Rapid Test
SARS-CoV-2 IgM Antibody Rapid Test
SARS-CoV-2 Antigen Rapid Test (Immunochromatography)

24

上海科华生物工程股份有限公司
Shanghai Kehua Bio-engineering Co., Ltd.

91310000132660318J

CE

Diagnostic kit for SARS-CoV-2 Nucleic Acid Real Time PCR(Real Time PCR)
Diagnostic kit for SARS-CoV-2 IgG/IgM Antibody(Colloidal Gold)(SARS-CoV-2 IgG/IgM Antibody)

25

丹娜（天津）生物科技股份有限公司
Dynamiker Biotechnology(Tianjin) Co., Ltd.

911201160931130117

CE

2019-nCOV IgG/IgM Rapid Test
Model:DNK-1419-1
Dynamiker SARS-CoV-2 Ag Rapid Test
Novel Coronavirus (2019-nCoV) RT-PCR Kit
2019-nCOV IgG Antibody kit (ELISA)
2019-nCOV IgM Antibody kit (ELISA)
Dynamiker SARS-CoV-2 Neutralization Antibody Rapid Test
Dynamiker SARS-CoV-2 Neutralization Antibody ELISA Assay
Dynamiker COVID-19/Influenza A+B Ag Combo Rapid Test
Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva)
Novel Coronavirus (2019-nCoV) RT-PCR Kit (Saliva)

26

杭州博拓生物科技股份有限公司
Hangzhou Biotest Biotech Co., Ltd

9133010079969193XF

CE

Biotes COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasm)
SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)
COVID-19 Antigen Rapid Test Cassette
SARS-CoV-2+Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
Novel Coronavirus SARS-CoV-2 Angiten Rapid Test Cassette
COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
COVID-19+Flu A&B+RSV Antigen Combo Rapid Test Cassette
COVID-19+Flu A&B+RSV+Adenovirus Antigen Combo Rapid Test Cassette
SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette

27

杭州创新生物检控技术有限公司
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

913301007441160062

CE

COVID-19 IgG/IgM Rapid Test Device,COVID-19 Antigen Rapid Test Device

28

杭州德安奇生物工程有限公司
Hangzhou Deangel Biological Engineering Co., Ltd

91330110589868581E

CE

COVID-19 IgG&IgM Rapid Test Device(WB/S/P) COVID-19-D02
Novel Coronavirus Spike Glycoprotein (S Protein) Detection Kit (Ligand-receptor competitive chromatography)

29

杭州迪安生物技术有限公司
Hangzhou DIAN Biotechnology Co., Ltd

9133011009204064XN

CE

Real-time RT-PCR Detection Kit For 2019-nCoV 48 Tests/Kit
Reagent of Nucleic Acid Extraction or Purification 64 Tests/Kit
Nucleic Acid Purification System EB-1000
COVID-19 Antigen Test Cassette
SARS-CoV-2 Neutralizaion Antibody Detection Kit

30

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.

91330108589866519M

CE

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit(Colloidal Gold)
Novel Coronavirus (2019-nCoV) IgM Antibody Combo Test Kit(Colloidal Gold)
Novel Coronavirus (2019-nCoV) IgG Antibody Combo Test Kit(Colloidal Gold)
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
COVID-19 and Influenza A/B Antigen Test Kit
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

31

杭州隆基生物技术有限公司
Hangzhou Clongene Biotech Co., Ltd.

913301107620252127

CE

Clongene COVID-19 IgG/IgM Rapid Test
COVID-19 Antigen Rapid Test
SARS-CoV-2 Nucleic Acid RT-PCR Test Kit
COVID-19/Influenza A+B Antigen Combo Rapid Test
COVID-19 Antigen Rapid Test Cassette (Nasal Swab)
COVID-19 Neutralization Antibody FIA
COVID-19 Antigen Rapid Test Cassette (Saliva)

32

杭州泰熙生物技术有限公司
Hangzhou Testsea biotechnology Co., Ltd.

91330110MA27W8H87B

CE

SARS-Cov-2 IgG/IgM Test Cassette(Colloidal gold)
SARS-CoV-2RT-qPCR Detection kit
COVID-19 Antigen Test Cassette
Flu A/B + COVID-19 Antigen Combo Test Cassette
COVID-19 Antigen Test Cassette (saliva)
SARS-CoV-2 Neutralizing Antibody Detection Kit (ELISA)
SARS-CoV-2 Neutralizing antibody Test Cassette

33

杭州微策生物技术股份有限公司
Vivachek Biotech (Hangzhou) Co., Ltd.

913301000743141922

CE

VivaDiag COVID-19 IgM/IgG rapid test, VivaDiag Influenza A+B Rapid Test, In Vitro Diagnostic Tests Kits based on fluorescent immunochromatography
VivaDiag SARS-CoV-2 Ag Rapid Test (VCD05)
VivaDiag SARS-CoV-2 Ag FIA Test (VID44)
VivaDiag SARS-CoV-2/Flu A/Flu B Ag Rapid Test (Colloidal Gold) (VLD01)
VivaDiag SARS-CoV-2/Flu A/Flu B Ag FIA Test (Fluorescence Immunochromatography) (VID47)
VivaDiag Pro SARS-CoV-2 Ag Rapid Test (VCD16)
SARS-CoV-2 Ag Saliva Rapid Test (VCD17)
SARS-CoV-2 Neutralizing Antibody FIA Test Kit (VID48)

34

杭州协合医疗用品有限公司
Hangzhou Singclean Medical Products Co., Ltd           

91330101747181911R

CE

COVID-19 IgG Test kit(Colloidal Gold Method)
COVID-19 IgG/IgM Test kit(Colloidal Gold Method)
COVID-19 IgM Test kit(Colloidal Gold Method)
COVID-19 Test kit(Colloidal Gold Method)
COVID-19 Antigen Test Kit (Colloidal Gold)
COVID-19 & FLU A/B Antigen Test Kit (Colloidal Gold)

35

康永生物技术有限公司
Prometheus Bio Inc.

91330101MA2CFB2J1T

CE

2019-nCoV IgG/IgM Test Cassette(WHOLE Blood/Serum/Plasma)
2019-nCoV Neutralizing Antibody Test Cassette (Whole Blood/Serum/Plasma)

36

美康生物科技股份有限公司
Medicalsystem Biotechnology Co., Ltd

913302007503871799

CE

Coronavirus Disease 2019 Antibody (IgM/IgG)Combined Test Kit, Coronavirus Disease 2019 Real Time PCR Kit,Nucleic Acid Extraction or Purification Reagent, SARS-CoV-2 RT-PCR Test Kit
COVID-19 Ag Rapid Test Cassette
COVID-19 & Influenza Antigen Rapid Test Cassette

37

浙江东方基因生物制品股份有限公司
Zhejiang Orient Gene Biotech Co.,Ltd.

913305007804719612

CE

COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
Coronavirus Ag Rapid Test Cassette (Swab)
Influenza & COVID-19 Ag Combo Rapid Test Cassette (Swab)
Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)
SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR)
SARS-CoV-2 K417N/E484K Mutations Detection Kit (Fluorescence PCR)
SARS-CoV-2 N501Y/HV69-70del Mutations Detection Kit (Fluorescence PCR)
SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) 
SARS-CoV-2 Detection Kit (Direct Fluorescence PCR)
SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)
SARS-CoV-2 Ab & NAb Rapid Test Cassette (Whole Blood/Serum/Plasma)

38

中翰盛泰生物技术股份有限公司
Joinstar Biomedical Technology Co.,Ltd.

913301005660614000

CE

SARS-CoV-2 IgM/IgG Antibody Test(Colloidal Gold)
COVID-19 Antigen Rapid Test (Latex)
SARS-CoV-2 /MERS-CoV /Influenza A&B Antigen Rapid Test (Latex)
COVID-19 Antigen Rapid Test (Colloidal Gold)
SARS-CoV-2/Influenza A&B Antigen Rapid Test
SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold)

39

重庆中元汇吉生物技术有限公司
Zybio Inc.      

915001043278176610

CE

SARS-CoV-2 IgM/IgG Assay Kit (Colloidal Gold Method)
SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method)
SARS-CoV-2 Antibody Assay (CLIA)
SARS-CoV-2 Neutralizing Antibody Assay (CLIA)
SARS-CoV-2 Neutralizing Antibody Assay (Colloidal Gold)
SARS-CoV-2 Neutralizing Antibody Assay (ELISA)
Zybio SARS-CoV-2 Assay Kit
Molaccu COVID-19 Detection Kit
2019-nCoV Neutralizing Antibody Assay (Colloidal Gold)
SARS-CoV-2 & Influenza A/B Antigen Assay Kit (Colloidal Gold Method)

40

艾维可生物科技有限公司
Avioq Bio-tech Co.,Ltd.

91370613MA3C5MUG2H

CE

Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Assay Kit (Colloidal Gold)

41

杭州安旭生物科技股份有限公司
Assure Tech (Hangzhou) Co., Ltd.

913301066767726252

CE

COVID-19 Rapid Test
COVID-19 Antigen Rapid Test Device
FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device
COVID-19 & Influenza A/B Antigen Combo Test Device
COVID-19 & M. pneumoniae Antigen Combo Test Device
COVID-19 Neutralizing Antibody FIA

42

基蛋生物科技股份有限公司
Getein Biotech, Inc.

913201007360621166

CE

One Step Test for Novel Coronavirus(2019-nCoV) IgG antibody (Colloidal Gold)
One Step Test for Novel Coronavirus(2019-nCoV) IgM antibody (Colloidal Gold)
One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit
Akso SARS-CoV-2 Real-time RT-PCR Kit
SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)
One Step Test for SARS-CoV-2 Total Antibody/Neutralizing Antibody (Colloidal Gold)
One Step Test for FluA/FluB/SARS-CoV-2 Antigen (Colloidal Gold)
SARS-CoV-2 Total Antibody/Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay)
FluA/FluB/SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)
FluA/FluB/SARS-CoV-2 Real-time RT-PCR Kit
SARS-CoV-2/VOC-202012/01 Real-time RT-PCR Kit
SARS-CoV-2/501.V2 Real-time RT-PCR Kit

43

江苏美克医学技术有限公司
Jiangsu Medomics Medical Technology Co.,Ltd.

91320191MA1RA46X7Q

CE

19 types of respiratory pathogens nucleic acid multiplex test panel (SARS-CoV-2 included, Fluorescent Probe-based real-time PCR assay)
A Rapid IgM-IgG Combined Antibody Test Kit for SARS-CoV-2(ICA)
Influenza A, Influenza B andSARS-CoV-2 nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
SARS-CoV-2 (ORF1ab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
SARS-CoV-2 antigen Test Kit (ELISA)
SARS-CoV-2 antigen Test Kit(LFIA)
SARS-CoV-2 Neutralizing antibody Test Kit (ELISA)
SARS-CoV-2 Neutralizing antibody Test Kit(LFIA)
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid

44

三诺生物传感股份有限公司
Changsha Sinocare Inc.

91430100740620301T

CE

SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method)
SARS-CoV-2 IgM/IgG Antibody Test Kit

45

上海思路迪生物医学科技有限公司
3D Biomedicine Science & Technology Co., Limited

91310112MA1GBGBP12

CE

3DMed 2019-nCoV RT-qPCR Detection Kit
ANDiS SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit
ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit

46

南京黎明生物制品有限公司
Nanjing Liming Biological Products Co., Ltd.

9132010272837745XD

CE

SARS-CoV-2 Antigen Rapid Test

47

北京健乃喜生物技术有限公司
Beijing Genesee Biotech ,inc.
（持证公司：CTK Biotech, Inc.）

91110116679618092L

CE

OnSite COVID-19 gG/IgM Rapid Test
Aria COVID-19 gG/IgM Rapid Test
CLINITEST Rapid COVID-19 Antigen Test
OnSite COVID-19 Ag Rapid Test
Aria COVID-19 Ag Rapid Test
Answer COVID-19 Ag Rapid Test
ad-bio COVID-19 Ag Rapid Test
ImmuView COVID-19 Ag Rapid Test
Aria COVID-19 + Influenza A/B Ag Rapid Test
OnSite COVID-19 + Influenza A/B Ag Rapid Test

48

苏州新波生物技术有限公司
Suzhou SYM-BIO Life Science Co., Ltd.
（持证公司：PerkinElmer, Inc.）

913205857287201588

U.S. FDA EUA

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

49

赛莱克斯生物科技（苏州） 有限公司
Cellex Biotech (Suzhou) Co., Ltd.
（持证公司：Cellex INC）

91320505321623444A

U.S. FDA EUA

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test

50

赛莱克斯生物科技（苏州） 有限公司
Cellex Biotech (Suzhou) Co., Ltd.
（持证公司：Cellex INC）

91320505321623444A

TGA

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test

51

江苏百世诺医疗科技有限公司
Bestnovo (Jiangsu) Medical Technology Co., Ltd.

91321291MA1MCU5B8G

CE

Novel Coronavirus (SARS-CoV-2) nucleic acid detection Kit(real-time fluorescent RT-PCR)
COVID-19 IgG/IgM Antibody Diagnostic Kit (Colloidal Gold Immunochromatography Assay)
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)

52

深圳市普瑞康生物技术有限公司
Shenzhen Puruikang Biotech Co.,Ltd

91440300691158527J

CE

Detection Kit for 2019-Novel Coronavirus RNA (RT-PCR-Fluorescence Probing)

53

广州市宝创生物技术有限公司
Guangzhou Biotron Technology Co., Ltd

914401166986583053

CE

COVID-19 IgG/IgM Rapid Test Kit(Colloidal Gold Chromatography)
The Novel Coronavirus(2019-nCoV)Nucleic Acid test Kit （RT-PCR）

54

北京金豪制药股份有限公司
Beijing Kinghawk Pharmaceutical Co.,Ltd

91110302102033639G

CE

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR)
 IgM/IgG Antibody Detection Kit (Quantum Dot-based Fluorescence Immunochromatography)

55

南通伊仕生物技术股份有限公司
Nantong Egens Biotechnology Co. Ltd.

91320600718557959C

CE

COVID-19 IgG/IgM Rapid Test Kit

56

深圳市亚辉龙生物科技股份有限公司
Shenzhen YHLO Biotech Co., Ltd.

91440300680376756U

CE

iFlash-SARS-CoV-2 IgG
iFlash-SARS-CoV-2 IgM
iFlash-2019-nCoV Antigen
UNICELL-2019-nCoV Ag
iFlash-2019-nCoV IgA
GLINE-2019-nCoV IgA
GLINE-2019-nCoV IgM/IgG
iFlash-2019-nCoV Nab
UNICELL-2019-nCoV Nab
GLINE-2019-nCoV Ag

57

广州市微米生物科技有限公司
Guangzhou Weimi Bio-Tech Co., Ltd.

91440116078417690A

CE

Diagnostic Kit for novel coronavirus (COVID-19) IgM & IgG Antibody (Colloidal Gold)
COVID-19 Antigen Detection Reagent (Colloidal Gold method)
Coronavirus disease (COVID-19) & Influenza A/B Antigen Combo Detection Reagent (Colloidal Gold method)

58

深圳泰乐德医疗有限公司
Shenzhen Tailored Medical Ltd.

9144030009439947X0

CE

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit
Novel Coronavirus (SARS-CoV-2) IgM IgG Antibody Assay Kit

59

四川新健康成生物股份有限公司
Sichuan Xincheng Biological Co., Ltd

9151010079780219XP

CE

SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method

60

迈克生物股份有限公司
Maccura Biotechnology Co., Ltd.
（持证公司：Maccura Biotechnology (USA) LLC）

9151000020186004X7               

U.S. FDA EUA

SARS-CoV-2 Fluorescent PCR Kit

61

厦门市波生生物技术有限公司
Xiamen Boson Biotech Co.,Ltd

91350200705468594R

CE

2019-nCoV IgG/IgM Combo Test Card
Rapid SARS-CoV-2 Antigen Test Card
Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card
Anti-SARS-CoV-2 S Protein Antibody Quantitative Test
SARS-CoV-2 Neutralizing Antibody Test Card
SARS-CoV-2 Neutralizing Antibody Quantitative Test
SARS-CoV-2 Antigen Saliva Test Card
Anti-SARS-CoV-2 S Protein Antibody Test Card

62

安邦（厦门）生物科技有限公司
Anbio (Xiamen) Biotechnology Co.,Ltd

91350205MA34HD1E54

CE

COVID-19 IgM/IgG Antibody Colloidal Gold Test
Rapid  COVID-19 Antigen Test (Golloidal Gold)
Rapid Neutralizing Antibody of SARS-CoV-2 Test (Colloidal Gold)
Neutralizing Antibody of SARS-CoV-2 Test (Fluorescence Immunochromatographic Assay)

63

英科新创（厦门）科技股份有限公司
InTec Products, Inc.

91350200612005312M

CE

Rapid SARS-CoV-2 Antibody (IgG/IgM) Test (REF: ITP16002-TC25, ITP16001-TC25)
Rapid SARS-CoV-2 Antibody Test (REF: ITP16003-TC40, ITP16004-TC40)
Rapid SARS-CoV-2 Antibody (IgG/IgM) Test (REF: ITP16002-TC25, ITP16001-TC25)
Rapid SARS-CoV-2 Antigen Test (REF: ITP16010-TC25)

64

厦门致善生物科技股份有限公司
Xiamen Zeesan Biotech Co., Ltd.

91350200556210281J

CE

SARS-CoV-2 Test Kit
Packing Specification:48 Tests/Kit

65

厦门安普利生物工程有限公司
Xiamen Amplly Biotechnology Co.,Ltd.

91350200612333260F

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Real-Time RT-PCR),SARS-CoV-2 IgM/IgG Rapid Test
SARS-CoV-2 Antigen Rapid Test

66

德必碁生物科技（厦门）有限公司
TBG Biotechnology Xiamen Inc.

913502000793739255

CE

Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) type:24 tests/kit
Corona Virus Disease-19(COVID-19) IgG/IgM Rapid Cassette(S/P/WB)  type:25 tests/kit
Corona Virus Disease-19 (COVID-19) IgG/IgM Rapid Cassette (S/P/WB)

67

武汉璟泓科技股份有限公司
Wuhan J.H.BIO-TECH Co.,Ltd

914201007713964378

CE

SARS-CoV-2(COVID-19) IgG/IgM Antibody Fast Detection  Kit(Colloidal Gold)
Types: 1 Test/Bag, 1Test/Box, 5 Tests/Box, 10 Tests/Box, 25Tests/Box, 50 Tests/Box

68

武汉优恩生物科技有限公司
Wuhan UNscience Biotechnology Co., Ltd

91420100555037544L

CE

COVID-19 IgG/IgM Rapid Test kit
Types: 20T/40T/50T/100T
SARS-CoV-2 Antigen Rapid Test Kit
SARS-CoV-2 & Influenza Antigen Combo Rapid Test Kit

69

武汉康录生物技术股份有限公司
Wuhan HealthCare Biotechnology Co., Ltd.

914201000630003905

CE

Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)

70

江西省金洹医疗器械股份有限公司
Jiangxi Province Jinhuan Medical Instrument Co., Ltd.

913601005761160220

CE

(COVID-19)IgM/IgG Antibody Fast Detection Kit(Colloidal Gold)
Type:20 tests/kit
Novel coronavirus (SARS-CoV-2) antigen rapid detection kit

71

四川沃文特生物技术有限公司
Sichuan Orienter Biotechnology Co., Ltd

91510100577371682N

CE

COVID-19 IgG Antibody Detection Kit  (Chemiluminescence Method),COVID-19 IgM  Antibody Detection Kit (Chemiluminescence Method),
Novel Coronavirus (SARS-CoV-2) IgM / IgG Antibody Test Kit (Colloidal Gold)

72

天津中新科炬生物制药股份有限公司
NewScen Coast Bio-pharmaceutical Co., Ltd

9112011674912841XT

CE

COVID-19 IgG/IgM Rapid Test Cassette
COVID-19 IgG/IgM Microfluidic Chip
COVID-19 Ag & Influenza Combo Rapid Test
COVID-19 Antigen Rapid Test Cassette
COVID-19 Antigen Microfluidic Triple Test
COVID-19 Antigen Microfluidic Chip
COVID-19 Microfluidic Combo Test

73

江苏康尚生物医疗科技有限公司
Jiangsu Konsung Bio Medical Science and Technology Co.,Ltd

913211810618686552

CE

Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Type:1 PCS/box, 25PCS/box, 50PCS/box
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)

74

上海良润生物医药科技有限公司
Shanghai Liangrun Biomedicine Technology Co., Ltd.

913100000781742111

CE

Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19
Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (LFD method)
LionRunTM SARS-CoV-2 Antigen Rapid Test Kit
LionRun™ Flu A/B & COVID-19 Ag Combo Test (Lateral Flow Immunoassay)

75

山东探真生物科技有限公司
Shandong BioTruthSearch Co., Ltd
（持证公司：Biopanda Reagents Ltd.）

91370800MA3C6H0J87

CE

COVID-19 Rapid Test Kit (RAPG-COV-019)
COVID-19 Rapid Antigen Test Kit (RAPG-CVA-019)

76

西安金磁纳米生物技术有限公司
Xi'an GoldMag Nanobiotech Co., Ltd.

91610131561463697W

CE

Real-Time RT-PCR assays for the detection of SARS-CoV-2;
SARS-CoV-2 IgG/IgM Antibody Testing Kit(Magnatic Particle Lateral Flow Immunoassay)

77

陕西佰美基因股份有限公司
Shaanxi Lifegen Co., Ltd.

91610000719781266L

CE

Novel coronavirus (COVID-19) nucleic acid detection kit

78

上海贝西生物科技有限公司
Shanghai B&C Biological Technology Co., Ltd.

913100007780683054

CE

SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold Chromatography Method)
SARS-CoV-2 IgM/IgG Antibody Test (Latex Chromatography Method)

79

上海复星长征医学科学有限公司
Shanghai Fosun Long March Medical Science Co., Ltd.
（持证公司：Fosun Pharma USA Inc.）

91310113607209011M

U.S. FDA EUA

Fosun COVID-19 RT-PCR Detection Kit

80

上海复星长征医学科学有限公司
Shanghai Fosun Long March Medical Science Co., Ltd.

91310113607209011M

CE

Fosun 2019-nCoV qPCR;
Fosun 2019-nCoV rapid;
Fosun FluA/FluB/2019-nCoV qPCR;
Fosun RSV rapid;
Fosun CP/MP rapid;
Fosun 2019-nCoV IgM/IgG test Kit

81

北京协和洛克生物技术有限责任公司
Beijing Unionluck Biological Technology Co.,Ltd.

91110108600406944L

CE

Diagnostic Kit for Detection of IgG/IgM Antibody to SARS-CoV-2 (Colloidal gold)

82

北京林科特科技发展有限公司
Atlas Link (Beijing) Technology Co., Ltd

91110107758733005J

CE

NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold)

83

北京康美天鸿生物科技有限公司
Kangmei Tianhong Biotech (Beijing) Co., Ltd.

91110108672820570X

CE

COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
Model:20T/kit
Nucleic Acid Diagnostic Kit for SARS-CoV-2 (Fluorescence PCR)
Model:32T/kit
COVID-19 SARS-CoV-2 Antigen Assay Kit (Colloidal Gold)
SARS-CoV-2 IgG Antibody Test Kit (Fluorescence immunochromatography)

84

科赫生物科技（北京）有限公司
Koch Biotechnology (Beijing) Co., Ltd.

91110106335498920G

CE

SARS-CoV-2 Antigen and Antibody Lateral Flow Assay
SARS-CoV-2 IgM Lateral Flow Assay
SARS-CoV-2 IgG Lateral Flow Assay
SARS-CoV-2 Antigen Lateral Flow Assay
COVID-19 IgM/IgG Repid Test Strip
COVID-19 Antigen Rapid Test Kit

85

卡尤迪生物科技（北京）有限公司
Coyote Bioscience Co., Ltd

911101086976869886

CE

DirectDetct™ SARS-CoV-2 Detection Kit (PCR-Flurorescence Probe)

86

北京捷乐生物科技有限公司
Beijing Jiele Biotechnology Co.,Ltd.

911103025531476434

CE

SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Immunochromatography Method)
SAR-COV-2 Ag Rapid Test Cassette

87

迈克生物股份有限公司
Maccura Biotechnology Co., Ltd.

9151000020186004X7              

CE

Severe Acute Respiratory Syndrome Coronavirus 2(SRAR-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
SARS-CoV-2 IgG (CLIA)
SARS-CoV-2 IgM (CLIA)

88

深圳迈瑞生物医疗电子股份有限公司
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

914403007084678371

CE

Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA)
Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA)
SARS-CoV-2 IgG Positive Control
SARS-CoV-2 IgM/IgG Negative Control
SARS-CoV-2 IgM Positive Control
Severe Acute Respiratory Syndrome Coronavirus 2 neutralizing antibody (CLIA)
Severe Acute Respiratory Syndrome Coronavirus 2 S-RBD IgG (CLIA)
SARS-CoV-2 NT Antibody Control (L)
SARS-CoV-2 NT Antibody Control (H)
SARS-CoV-2 S-RBD IgG Antibody Control (L)
SARS-CoV-2 S-RBD IgG Antibody Control (H)

89

珠海丽珠试剂股份有限公司
Zhuhai Livzon Diagnostics Inc.

91440400617488114A

CE

Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)
Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay)

90

珠海丽珠试剂股份有限公司
Zhuhai Livzon Diagnostics Inc.

91440400617488114A

TGA

Severe acute respiratory syndrome-associated coronavirus IVDs

91

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co., Ltd.

91330108589866519M

TGA

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit(Colloidal Gold)

92

潮州凯普生物化学有限公司
Chaozhou Hybribio Biochemistry Ltd.

91445100761585197P

CE

COVID-19 Real-time RCR Kit, HBRT-COVID-19

93

广州天宝颂原生物科技开发有限公司
Guangzhou Tebsun Bio-Tech Development Co., Ltd.

91440101661840488L

CE

SARS-CoV-2 Nucleic Acid Test
SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatographic Assay)
Gold Immunochromatographic Assay）
SARS-CoV-2 Antigen Test Kit（Colloidal Gold Immunochromatographic Assay）
SARS-CoV-2 Nucleic Acid Test Kit(Lyophilized)
 SARS-CoV-2 Nucleic Acid Test Kit(Fluorescence assay)
SARS-CoV-2 Nucleic Acid Test Kit(Fluorescence assay and Lyophilized)

94

广州万孚生物技术股份有限公司
Guangzhou Wondfo Biotech Co., Ltd.

91440101618640472W

CE

Finecare™ SARS-CoV-2 lgM Test – Cat. No.: W277
Finecare™ SARS-CoV-2 Antibody Test – Cat. No.: W276
Finecare™ SARS-CoV-2 IgM/IgG Test
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Wondfo SARS-CoV-2 Real-Time RT-PCR Assay
Wondfo SARS-CoV-2 IgM Antibody Test (Lateral Flow Method)
Wondfo SARS-CoV-2 IgG Antibody Test (Lateral Flow Method)
Finecare™ SARS-CoV-2 IgG Test - W280
Finecare™ SARS-CoV-2 Antigen Test – W286
Finecare™ 2019-nCoV Antigen Test (REF: W286)
Wondfo 2019-nCoV Real-Time RT-PCR Assay (REF: W275P001, W275P002, W275P003, W275P004)
Finecare™ 2019-nCoV Antibody Test (REF: W276)
Finecare™ 2019-nCoV IgG Test (REF: W280)
Finecare™ 2019-nCoV IgM Test (REF: W277)
Wondfo 2019-nCoV IgG Antibody Test (Lateral flow method) (REF: W198)
Wondfo 2019-nCoV IgM Antibody Test (Lateral flow method) (REF: W197)
Wondfo 2019-nCoV Antibody Test (Lateral Flow Method) (REF: W195P0002)
Finecare™ 2019-nCoV IgM/IgG Test (REF: W278)
2019-nCoV Neutralizing Antibody Rapid Test - REF: W631P0002, W631P0003, W631P0004, W631P0005, W631P0006, W631P0007, W631P0008, W631P0009, W631P0010, W631P0011
2019-nCoV RBD Antibody Rapid Test - REF: W632P0002, W632P0003, W632P0004, W632P0005, W632P0006, W632P0007, W632P0008, W632P0009, W632P0010, W632P0011
Finecare™ 2019-nCoV Neutralizing Antibody Test - REF: W289P0001, W289P0002, W289P0003, W289P0004, W289P0005, W289P0006, W289P0007, W289P0008, W289P0009, W289P0010
Finecare™ 2019-nCoV RBD Antibody Test - REF: W290P0001, W290P0002, W290P0003, W290P0004, W290P0005, W290P0006, W290P0007, W290P0008, W290P0009, W290P0010
2019-nCoV Neutralizing Antibody Detection Kit (Chemiluminescence Immunoassay) - REF: WA37P0001, WA37P0003
2019-nCoV RBD Antibody Detection Kit (Chemiluminescence Immunoassay) - REF: WA38P0001, WA38P0003

95

深圳市爱康试剂有限公司
Aikang Diagnostics Co., Ltd.

914403000758441870

CE

SARS-CoV-2 Antigen Test Kit (Immunochromatography)
Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Combined Test Kit (Colloidal Gold Immunochromatographic Assay)

96

深圳市新产业生物医学工程股份有限公司
Shenzhen New Industries Biomedical Engineering Co., Ltd.

914403001923998520

CE

2019-nCoV IgM (CLIA)
2019-nCoV IgG (CLIA)
SARS-CoV-2 S-RBD lgG (CLIA)
SARS-CoV-2 RT-PCR Assay
SARS-CoV-2 Neutralizing Antibody (CLIA)
SARS-CoV-2 & Flu A/B RT-PCR Assay
SARS-CoV-2 Ag (CLIA)
SARS-CoV-2, Flu & RSV RT-PCR Assay

97

深圳加美生物有限公司
Shenzhen JetMay Care Limited

91440300MA5ERUQ62X

CE

COVID-19 IgM & lgG Test (lmmunochromatography)

98

深圳联合医学科技有限公司
Shenzhen Uni-medica Technology Co.,Ltd.

91440300582717668H

CE

Real Time PCR Kit for Novel Coronavirus
2019-nCoV (ORF1ab,N)
Multiplex Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab)/Influenza A/Influenza B
Real Time PCR Kit for Novel Coronavirus 2019-nCoV
Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N, E)
Freeze-Dried Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N)

99

中山市创艺生化工程有限公司
Zhongshan Chuangyi Biochemical Engineering Co.,Ltd

91442000712312504C

CE

COVID-19 IgM/IgG Detection Kit (Colloidal Gold)
COVID-19 IgM/IgG Detection Kit (Immunofluorescence)

100

厦门奥德生物科技有限公司
Xiamen AmonMed Biotechnology Co., Ltd.

913502050899181912

CE

COVID-19 IgM/IgG test kit (Colloidal Gold)
COVID-19 IgM/IgG test kit (Rare earth nano fluorescence immunochromatography)
COVID-19 (ORF1ab/E/N Gene) Nucleic Acid Diagnostic Kit (Triple Fluorescence PCR Method)
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
COVID-19/Influenza A/Influenza B Virus Antigen Assay Kit (Colloidal Gold)
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold)
COVID-19 Neutralizing Antibody Test Kit (Rare earth nano fluorescence immunochromatography)
COVID-19/Influenza A virus/Influenza B virus IgM combo test kit (Rare earth nano fluorescence immunochromatography)
COVID-19/Influenza A virus/Influenza B virus test kit (Rare earth nanofluorescence immunochromatography)

101

深圳市迈科龙生物技术有限公司
Shenzhen Microprofit Biotech Co., Ltd.

91440300685395462N

CE

SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay)
SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)
SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)
SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)

102

深圳市绿诗源生物技术有限公司
Shenzhen Lvshiyuan Biotechnology Co., Ltd

914403007576264357

CE

Covid-19 (2019-nCoV) Coronavirus IgG / IgM Rapid Tset Kit
SARS-CoV-2 Antigen Rapid Test Kit
Flu A & Flu B & COVID-19 Ag Rapid Test

103

广东华银医药科技有限公司
Guangdong Huayin Medicine Science Co.,Ltd

91440116766148930W

CE

Detection Kit for 2019-nCoV RNA(Multiple RT-PCR Fluorescence Probing)( Lyophilised)

104

常州博闻迪医药股份有限公司
Changzhou Biowin Pharmaceutical Co., Ltd.

913204055866144395

CE

Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit
Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (Florescence RT-PCR)
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

105

江苏圣极基因科技有限公司
Jiangsu Saint Genomics Technology Co., Ltd.

91320301MA1PYEE20H

CE

Novel Coronavirus (SARS-CoV-2) Real-Time PCR Kit, SaintMax Viral DNA / RNA Isolation Kit (Method of magnetic heads)

106

扬州金麦德进出口有限公司
Yangzhou Goldmed Import&Export Co.,Ltd

913210033239176307

CE

COVID-19 IgG/IgM Rapid Test Kit(Colloidal Gold)

107

江苏康为世纪生物科技股份有限公司
Jiangsu CoWin Biotech Co., Ltd

91321291561773986P

CE

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 

108

南京诺唯赞医疗科技有限公司
Nanjing Vazyme Medical Technology Co., Ltd.

91320192MA1MFEWD9E

CE

2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)
SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit(Colloidal Gold-Based)
Novel Coronvairus(SARS-CoV-2) and Influenza A/B Virus RT- qPCR Detection Kit
Anti-SARS-CoV- 2 Neutralizing Antibody ELISA Kit
Anti-SARS-CoV- 2 Neutralizing Antibody TR- FRET Kit
2019 Novel Coronavirus (2019-nCoV) TriplexRT-qPCR Detection Kit
DNA/RNA Extraction kit
Automatic nucleic acids extraction instrument
Anti-SARS-CoV- 2 Neutralizing Antibody ELISA Kit
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)
Novel Coronavirus(SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit

109

南京仁迈生物科技有限公司
Nanjing Realmind Biotech Co., Ltd

91320191339348399M

CE

SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)

110

南京帝准生物科技有限公司
Nanjing DiaZoom Biotech Co., Ltd.
（持证公司：DiaCarta, Inc. ）

91320191MA1WEBGC40

U.S. FDA EUA

QuantiVirus SARS-CoV-2 Test kit
QuantiVirus™ SARS-CoV-2 Multiplex Detection Test

111

博迪泰（厦门）生物科技有限公司
BioDetect（Xiamen）Biotechnology Co., Ltd.

91350203MA2YCU9R7H

CE

2019-nCoV IgG/IgM Combo Test Card                                （Colloidal gold)
2019-nCoV Molecular Diagnostic Kit (Fluorescent PCR Test)
RAPID SARS-CoV-2 Antigen Test Card
SARS-CoV-2, FluA/B combined Antigen Detection Kit

112

厦门人瑞生物医药科技有限公司
Xiamen Memorigen Co.,Ltd

913502000511581909

CE

Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (RT-PCR)

113

江苏苏博生物医学科技南京有限公司
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.

91320191MA1MFFL48D

CE

SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
SARS-CoV-2 (COVID-19) Nucleic Acid Detection Kit(Fluorescent RT-PCR)
COVID-19 Antigen Rapid Test Cassette(Latex immunochromatography)

114

江苏医联生物科技有限公司
Jiangsu Medunion Biotechnology Co., Ltd.

91321002MA1MHWC210

CE

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) nucleic acid test kit (Fluorescent Probebased realtime PCR assay)

115

南京世和医疗器械有限公司
Geneseeq Medical Device and Diagnostic Inc.

91320191MA1MBR352L

CE

SARS-CoV-2 Nucleic Acid Detection Kit (qRT-PCR)

116

天津贝罗尼生物科技有限公司
Tianjin Beroni Biotechnology Co.,Ltd.

911201113003925013

CE

SARS-CoV-2 IgG/IgM Antibody Detection Kit (Colloidal Gold)

117

合肥知恩生物技术有限公司
Hefei Zhi En Biotechnology Co.,Ltd.

90340100328083030U

CE

新冠病毒核酸检测试剂盒（荧光PCR）Detection Kit for Novel Coronavirus (SARS-CoV-2)
nucleic acid (Fluorescence PCR)
规格：96T 非无菌
抗新冠病毒总抗体检测试剂盒Detection Kit for Total Anti-covid-19 Virus Antibody
(Colloidal Gold Method)
规格：25T 非无菌

118

芜湖森爱驰生物科技有限公司
Wuhu 3H Biotechnology Co.,Ltd.

91340221MA2N2JN19K

CE

 COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)

119

深圳市国赛生物技术有限公司
Goldsite Diagnostics Inc.

914403007084983777

CE

SARS-CoV-2 IgG/IgM Kit
SARS-CoV-2 Antigen Kit (Colloidal Gold)

120

深圳市海普洛斯生物科技有限公司
HaploX Biotechnology Co., Ltd.

9144030031174500XP

CE

SARS-CoV-2 Antigen Assay Kit （Colloidal Gold Method）
Viral DNA/RNA Kit (Magnetic Bead Method)

121

深圳市赛格诺生物科技有限公司
SignalDT Biotechnologies (SZ), Inc.

91440300079845152D

CE

LyoDx® Freeze-Dried Real-Time RT-PCR Detection Kit for SARS-CoV-2
LyoDx® Freeze-Dried Multiplex Real-Time RT-PCR Detection Kit for SARS-CoV-2 and Influenza Viruses A&B
LyoDx® Freeze-Dried Real-Time RT-PCR Detection Kit for SARS-CoV-2

122

深圳市亿立方生物技术有限公司
Shenzhen Yilifang Biotech Co., Ltd.

9144030008011500X7

CE

SARS-CoV-2 Nucleic Acid Detection Kit
COVID-19 IgG/IgM Rapid Test Kit (colloidal gold)

123

深圳无微华斯生物科技有限公司
WWHS Biotech. Inc

91440300MA5DFLTH0U

CE

SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

124

深圳优迪生物技术有限公司
Shenzhen Ultra-Diagnostics Biotec. Co.,Ltd.

91440300MA5DFC619U

CE

Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG antibody Combined Test Kit
Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Test Kit（Colloidal Gold Chromatographic Immunoassay）
SARS-CoV-2 Antigen Control

125

益善生物技术股份有限公司
SurExam Bio-Tech Co.,Ltd

91440101795532704A

CE

COVID-19 IgM/IgG Rapid Test

126

中山市天洋电子生物传感器有限公司
Zhongshan Tianyang Electronic Biosensor Co., Ltd.

914420007292229196

CE

 SARS-CoV-2 IgM/IgG  Rapid Test  kit
SARS-CoV-2 Real time RT-PCR kit

127

珠海浪峰生物技术有限公司
Zhuhai Langfeng Biotech.Co.,Ltd

91440400617876002H

CE

SARS-CoV-2 IgG/IgM Rapid Test kit (colloidal Gold)
SARS-CoV-2 IgG ELISA Kit
SARS-CoV-2 IgM ELISA Kit
SARS-CoV-2 Real time PT-PCR Kit
SARS-CoV-2 Antigen Rapid Test Kit （Colloidal Gold）

128

英诺特（唐山）生物技术有限公司
Innovita (Tangshan) Biological Technology Co., Ltd.

91130283568909612G

CE

2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo)
Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR)
2019-nCoV Ag Test (Latex chromatography Assay)
2019-nCoV IgG Test (Colloidal Gold)
Flu A/Flu B/2019-nCoV Ag 3 in 1 Combo Test

129

河南省华之源生物技术有限公司
Henan Province OriginBio Biotechnology Co.,Ltd.

91410100MA44F2YYXK

CE

SARS-COV-2 Nucleic Acid Detection Kit (RT-PCR)

130

郑州安图生物工程股份有限公司
Autobio Diagnostics Co., Ltd.

914100007167932103

CE

Anti-SARS-CoV-2 Rapid Test
SARS-CoV-2 lgG CLIA Microparticles
SARS-CoV-2 lgM CLIA Microparticles
SARS-CoV-2 lgG II CLIA Microparticles
SARS-CoV-2 lgM II CLIA Microparticles
Anti-SARS-CoV-2 RBD Rapid Test
AutoMolec SARS-CoV-2 rRT-PCR
lnfluenza/SARS-CoV-2 Ag Combo Rapid Test
SARS-CoV-2 Ag Rapid Test
SARS-CoV-2 Neutralization Antibody CLIA Microparticles
Anti-SARS-CoV-2 RBD CLIA Microparticles

131

华大生物科技（武汉）有限公司
BGI Genomics Co.Ltd.

91420100081953881Y

U.S. FDA EUA

Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2

132

武汉友芝友医疗科技股份有限公司
Wuhan YZY Medical Science And Technology Co.,Ltd.

91420100578277233A

CE

COVID-19 Nucleic Acid Fluorescent PCR Detection Kit

133

湖南康润药业股份有限公司
Hunan Runkun Pharmaceutical Co., Ltd

9143060074061741XW

CE

SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

134

湖南省丽拓生物科技有限公司
Hunan Lituo Biotechnology Co.,Ltd

91430122680340606U

CE

COVID-19 IgG/IgM Detection Kit (Colloidal Gold)

135

湖南中科蓝海生物科技有限公司
Hunan Zhongke Lanhai Biotechnology Co., Ltd

91430211MA4Q0BUE3D

CE

Coronavirus disease (COVID-19) IgM/IgG Antibody Rapid Test (Colloidal Gold)

136

苏州康和顺医疗技术有限公司
Suzhou Kangheshun Medical Technology Co.,Ltd

9132050506948201XP

CE

SARS-CoV-2 IgG/IgM Rapid Test Cassette

137

山东德诺生物科技有限公司
Shandong Diano Bio-Tech Co.,Ltd

91370784MA3BY89A9U

CE

Detection Kit for 2019-novel Coronavirus antigen（Fluorescence immunochromatography Method）
Dry Immunofluorescence Quantitative Analyzer
Detection Kit for 2019-novel Coronavirus antigen（Fluorescence immunochromatography Method）
Detection Kit for IgM Antibody to 2019-novel Coronavirus (Colloidal Gold Immunochromatography Method)
Detection Kit for IgG antibody to 2019-novel Coronavirus (Colloidal Gold Immunochromatography Method)
Detection Kit for Antigen to SARS-CoV-2 (Colloidal Gold Immunochromatography Method)
Detection Kit for IgM/IgG antibody to SARS-CoV-2 (Fluorescence  Immunochromatography)
Detection Kit for RNA to SARS-CoV-2 (Fluorescent PCR Method)
Diagnostic Kit for 2019-novel coronavirus antigen (Fluorescence immunochromatography Method)
Detection Kit for IgM/IgG antibody to SARS-CoV-2 (Colloidal Gold Immunochromatography) (Double Sample Holes)
Detection Kit for IgM/IgG antibody to SARS-CoV-2 (Colloidal Gold Immunochromatography)

138

杭州博拓生物科技股份有限公司
Hangzhou Biotest Biotech Co.,Ltd
（持证公司：Citus Diagnostics Inc）

9133010079969193XF

CE

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 Antigen Rapid Test Cassette (Saliva)
SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)
SARS-CoV-2+Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)
Novel Coronavirus SARS-CoV-2 Antigen Rapid Test Cassette (Fluorescence immunochromatography)

139

杭州博旭生物技术有限公司
Hangzhou Bosure Biotech Co.,Ltd

913301020845510360

CE

SARS-CoV-2 IgG/IgM Rapid test devices (colloidal Gold)
SARS-CoV-2 Antigen Rapid test
SARS-CoV-2 & Influenza A+B Combo Test

140

杭州杰毅生物技术有限公司
Hangzhou Matridx Biotechnology Co., Ltd

91330106MA2GK5DQ3U

CE

SARS-CoV-2 Nucleic Acid Detection Kit (probe-based qRT-PCR)
2019-nCoV Nucleic Acid Detection Kit (CRISPR-based Nuleic Acid Detection)

141

杭州金溪生物技术有限公司
Hangzhou Genesea Biotechnology Co., Ltd

91330106589895782M

CE

COVID-19 IgG/IgM Rapid Test Cassette
SARS-CoV-2 antigen rapid test

142

杭州联晟生物科技有限公司
Hangzhou Lysun Biotechnology Co., Ltd.

91330108MA2B0TJL2M

CE

2019-nCoV IgG/IgM Rapid Test Device（colloidal Gold)
COVID-19 antigen Rapid Test Device (Colloidal Gold)
COVID-19 Neutralizing Antibody Rapid Test Device (Colloidal Gold)

143

杭州赛凯生物技术有限公司
Safecare Biotech(Hangzhou) Co.,Ltd.

9133011005670527XT

CE

COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)
COVID-19 Antigen Rapid Test Kit (Swab)
Multi-Respiratory Virus Antigen Test Kit (Swab) (Influenza A+B/ COVID-19)
COVID-19 Antigen Rapid Test Kit(Saliva)

144

杭州亿米诺生物科技有限公司
Hangzhou Immuno Biotech Co.Ltd

91330101092042370C

CE

Coronavirus COVID-19 IgG/IgM Antibody Rapid Test
SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab)
SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag)

145

杭州优思达生物技术有限公司
Ustar Biotechnologies (Hangzhou) Ltd.

91330108770806481W

CE

Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (PCR-Fluorescent Probe Assay)
2019-nCoV Antigen Rapid Test
2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay)
2019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay)

146

立凯生物技术（杭州）有限公司
Liclear Biotech(Hangzhou)Co.,Ltd.

91330106MA28MEFX12

CE

SARS-CoV-2 IgG/IgM Test Cassette (colloidal Gold)
SARS-COV-2 Antigen/FLU A +B Antigen Combo Rapid Test Cassette (Swab)
SARS-COV-2 Nucleocapsid (N) Antigen Rapid Test Cassette

147

宁波海尔施基因科技有限公司
Ningbo Health Gene Technologies Co., Ltd.

9133020158051033XQ

CE

SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method)

148

浙江峻山生物科技有限公司
Zhejiang Gene Science Co.,Ltd.

91330604MA2BDA930U

CE

Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)
Novel Coronavirus (SARS-CoV-2) & Influenza Antigen Combo Rapid Test Kit (Colloidal Gold Immunochromatography)
Rapid SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold)

149

安诺优达基因科技（北京）有限公司
Annoroad Gene Tech.（Beijing）Co., Ltd.

9111030259606926X6

CE

SARS-CoV-2 (ORF1ab/E Gene) Nucleic Acid Detection Kit  (Fluorescence QualitativeRT-PCR)

150

宝瑞源生物技术（北京）有限公司
Bao Ruiyuan Biotech (Beijing) Co., Ltd.

911101115657789526

CE

COVID-19 IgM/IgG Ab Test
COVID-19 IgG Ab Test
SARS-CoV-2(COVID-19) Fluorescence PCR  Kit
COVID-19 IgM Ab Test

151

北京安必奇生物科技有限公司
BeiJing Abace Biology Co.,Ltd

911103025621363052

CE

COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatography)

152

北京华晟源医疗科技有限公司
Beijing Hua Sheng Yuan Medical Technology Co., Ltd

91110114788604394H

CE

COVID-19 Virus Antigen Rapid Test Kit (colloidal gold)

153

广州市丰华生物工程有限公司
Guangzhou Fenghua Bioengineering Co.,Ltd.

914401017124923490

CE

SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

154

南京诺尔曼生物技术股份有限公司
Nanjing Norman Biological Technology Co., Ltd.

91320191674936331B

CE

Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)
Novel Coronavirus (COVID-19) and Influenza A/B Antigen Combo Testing Kit (Colloidal Gold)

155

深圳普门科技股份有限公司
Shenzhen Lifotronic Technology Co., Ltd.

91440300671851383C

CE

SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay)
SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)
SARS-CoV-2 IgM Assay Kits (Lateral Flow Immunoassay)
SARS-CoV-2 IgG Assay Kits (Lateral Flow Immunoassay)
SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)
SARS-CoV-2 Antigen (GICA)
SARS-CoV-2 Neutralization Ab(eCLIA)
SARS-CoV-2 Neutralization Ab(Lateral Flow Immunoassay)

156

珠海科域生物工程股份有限公司
Zhuhai Keyu Biological Engineering Co.,Ltd.

91440400562649645A

CE

SARS-CoV-2 IgM/IgG Rapid Test Kit (Immunochromatography)
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Assay)
SARS-CoV-2 IgG Detection Kit

157

宙斯生命科技(常州)有限公司
Zhousi Life Technology (Changzhou) Co., Ltd

91320412MA1WRBF6XQ

CE

Respiratory Pathogens IgM Test System(Multiple microbead immunoluminescence)

158

青岛爱博检测科技有限公司
Qingdao AIBO Diagnostic Co.,Ltd

9137028233413536XP

CE

Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Kit

159

深圳市晋百慧生物有限公司
Shenzhen Genebiohealth Co., Ltd.

914403000751775721

CE

SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR)

160

厦门市同普生物科技有限公司
Xiamen TopBiotech Co.,Ltd.

91350200M0001HL81J

CE

Detection Kit for Novel Coronavirus (SARS-CoV-2) (ORF1ab/N) RNA (RT-PCR)
Detection Kit for Novel Coronavirus (SARS-CoV-2) (ORF1ab/N/E)RNA (RT-PCR)
Cell Lysis Kit
Virus Lysis Kit

161

深圳华迈兴微医疗科技有限公司
Shenzhen Watmind Medical Co., Ltd.

9144030032622854XJ

CE

SARS-CoV-2 Ab Diagnostic Test Kit (Microfluidic chemiluminescence)
SARS-CoV-2 IgM Ab Diagnostic Test Kit (Microfluidic chemiluminescence)
SARS-CoV-2 IgG Ab Diagnostic Test Kit (Microfluidic chemiluminescence)
SARS-CoV-2 Ag Diagnostic Test Kit (Microfluidic chemiluminescence)
SARS-CoV-2 IgG/IgM Ab Diagnostic Test kit (Colloidal Gold)
SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)
SARS-CoV-2 Ag Diagnostic Test Kit (Immuo-fluorescence)
SARS-CoV-2/Influenza A+B Antigen Combo Test kit (Colloidal Gold)

162

江苏先声医疗器械有限公司
Jiangsu Simcere Medical Device Co.Ltd

91320102MA1X45YG17

CE

SARS-CoV-2 Nucleic Acid Detection Kit ( Fluorescence Qualitative RT-PCR)
SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit ( Colloidal-Gold Immunochromatographic Assay)

163

南京岚煜生物科技有限公司
Lansion Biotechnology Co., Ltd.

91320115MA1MXCYR9K

CE

(COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay)
Novel Coronavirus ( 2019-nCoV ) RNA Diagnostic Kit ( PCR Fluorescence
Probing)
COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)
SARS-CoV-2 Neutralizing Antibodies Test Kit (Dry Fluorescence Immunoassay)

164

南通戴尔诺斯生物科技有限公司
Nantong Diagnos Biotechnology Co.,Ltd

91320682550270187R

CE

(2019-nCoV)New coronavirus Antibody Test(Colloidal Gold)
（2019-nCoV)New coronavirus Antigen Test
COVID-19 & Influenza A+B Antigen Combo Test Kit (Colloidal Gold)

165

苏州海狸生物医学工程有限公司
Beaver Biomedical Engineering Co., Ltd

913205945837761683

CE

BeaverBeads Viral DNA/RNA Kit

166

北京安智因生物技术有限公司
Anngeen Biotechnology Co., Ltd.

91110115MA017K5L4X

CE

Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (by qRT-PCR)

167

北京贝尔生物工程股份有限公司
Beijing Beier Bioengineering Co., Ltd

91110115600040153J

CE

2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)
2019-New Coronavirus IgM Rapid Test Cassette (WB/S/P)
2019-New Coronavirus Antibody Rapid Test Cassette (Colloidal gold)
Anti-SARS-CoV-2 Antibody IgM Test Kit (ELISA)
Anti-SARS-CoV-2 Antibody IgG Test Kit (ELISA)
SARS-CoV-2 Total Ab Test Kit (ELISA)
Novel Coronavirus 2019-nCoV Nucleic Acid Test Kit (Fluorescence RT-PCR)
COVID-19 Antigen Rapid Test Kit
COVID-19 & Influenza A/B Rapid Test Kit

168

北京华大吉比爱生物技术有限公司
Beijing BGI-GBI Biotech Co., Ltd.
（持证公司：BGI Europe A/S）

91110108600023388J

CE

SARS-CoV-2 Virus IgM Antibody Detection Kit (ELISA)
SARS-CoV-2 Virus IgG Antibody Detection Kit (ELISA)
Real-time fluorescent RT-PCR kit for detecting SARS-COV-2

169

北京玛诺生物制药股份有限公司
Beijing Marr Bio-Pharmaceutical Co;Ltd

911101167786012299

CE

SARS-CoV-2 (COVID-19) IgG/IgM Antibody Fast Detection Kit (Colloidal Gold)

170

北京纳捷诊断试剂有限公司
Beijing Nagene Diagnosis Reagent Co., Ltd.

91110302348366775N

CE

Multiple Real-Time PCR kit for Detection of 2019-nCoV
Multiple Real-time PCR kit for detection of respiratory viruses

171

北京普恩光德生物科技开发有限公司
PerGrande BioTech Development Co., Ltd.

911101130673179778

CE

SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)

172

北京泰格科信生物科技有限公司
Beijing Tigsun Diagnostics Co., Ltd.

91110108766297223C

CE

Tigsun COVID-19 Combo IgM/IgG Rapid Test
Tigsun COVID-19 Antigen Rapid Test (FIA)
Tigsun COVID-19 Antigen Rapid Test
Tigsun COVID-19 Saliva Antigen Rapid Test

173

北京中检安泰诊断科技有限公司
Beijing Zhongjian Antai Diagnostic Technology Co., Ltd.

91110115699582197P

CE

Corona Virus (COVID-19) Combined (IgA/IgM/IgG) Rapid Test

174

蓝十字生物药业（北京）有限公司
Blue Cross Bio-Medical(Beijing)Co.,Ltd.

911101147415516435

CE

One Step Novel Coronavirus (SARS-CoV-2) IgM / IgG Test Kit
COVID-19 Antigen Test

175

华大生物科技（武汉）有限公司
BGI Biotechnology(Wuhan) Co.,Ltd.
（持证公司：BGI Europe A/S）

91420100081953881Y

CE

Real-time fluorescent RT-PCR kit for detecting SARS-COV-2
Real-time fluorescent RT-PCR kit for detecting 2019-nCoV
Nucleic Acid Detection Kit for SARS-COV-2 with Combinatorial Probe-Anchor Synthesis Technology
SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold)

176

吉林双正医疗科技有限公司
Surge Medical Inc.

91220106059635879J

CE

COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method)
COVID-19/Influenza A+ B Antigen Test Kit
COVID-19 Antigen Test Kit

177

拜澳泰克（沈阳）生物医学集团有限公司
Biotech & Biomedicine （Shenyang）Group Ltd.

91210114MA0P4DUU3D

CE

Real Time PCR Detection Kit For COVID-19 Coronavirus
Colorimetric And Isothermal Detection Kit For COVID-19 Coronavirus

178

沈阳优宁生物科技有限公司
Shenyang Union Biotechnology Co., Ltd.

91210112313241817W

CE

COVID-19 (2019-SARS-CoV-2) IgM/IgG Antibody Test Kit (Colloidal Gold)

179

奥然生物科技（上海）有限公司
Igenesis(Shanghai)Co.,Ltd.

91310115329614737B

CE

SARS-2-CoV (Covid-19) nucleic acid detection cartridge (Real-time reverse transicription PCR method)
Nucleic Acid Detection Kit for SARS-2-CoV (Covid-19) -Real-time reverse transcription PCR method

180

上海埃文医疗科技有限公司
Shanghai IVEN Medical Technology Co.,Ltd.

91310115084136326W

CE

COVID-19 IgG/IgM Rapid Test Kit (Colloidal gold)

181

上海凯创生物技术有限公司
Shanghai Chemtron Biotech.Co.,Ltd.

913101156074267293

CE

Novel Coronavirus (2019-nCoV)IgM/IgG Antibody Diagnostic Kit (Colloidal Gold)
Novel Coronavirus (2019-nCoV)IgM Antibody Diagnostic Kit (Colloidal Gold)
COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)
Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold)
Novel Coronavirus (2019-nCoV) IgG Antibody Diagnostic Kit
Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)
COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)
COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)

182

成都峰际生物技术有限公司
Foregene Co., Ltd.

91510115MA61UOCP37

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)

183

润方（长春）生物科技有限公司
Redpharm (Changchun) Biotechnology Co., Ltd

91220101MA153RY93U

CE

SARS-CoV-2 IgG/IgM Antibody Test Strip (Colloidal Gold Method)
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR)

184

浙江检康生物科技有限公司
Zhejiang Jiankang Biotech Co.,Ltd.

91320115593539879G

CE

COVID-19 Nucleic Acid Detection Kit (Fluorescence PCR)
SARS-CoV-2(COVID-19)IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)

185

杭州博日科技股份有限公司
Hangzhou Bioer Technology Co., Ltd.　

913301007399478414

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR)
SARS-CoV-2/ Influenza A Virus/ Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)
SARS-CoV-2 Antigen Test Kit (colloidal gold method)
SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method)
SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit

186

杭州海基生物技术有限公司
Hangzhou Higene Biotechnology Co., Ltd.

913301103282114853

CE

Real-time PCR Kit for Rapid Detection of SARS-COV-2
SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
SARS-CoV-2 Antigen Rapid Test
SARS-CoV-2 Antigen/ FLU A+B Antigen combo Rapid Test

187

杭州世佳电子有限公司
Hangzhou Sejoy Electronics &. Instruments Co.,Ltd

91330160742011788U

CE

COVID-19 lgG/lgM Rapid Test Cassette
SARS-CoV-2 Antigen Rapid Test Cassette

188

浙江鼎创医疗科技有限公司
Zhejiang TopstroMed Medical Technology Co., Ltd.

91330604MA2BDJWX72

CE

Real-time PCR Kit for Rapid Detection of Novel coronavirus (SARS-CoV-2)
Colloidal Gold COVID-19 IgM/IgG Antibodies Rapid Test Kit

189

浙江夸克生物科技有限公司
Zhejiang Quark Biotechnology Co.,Ltd.

913306247045036423

CE

Novel Coronavirus IgG/IgM Rapid Test Device (WB/S/P)

190

浙江安吉赛安芙生物科技有限公司
Zhejiang Anji Saianfu Biotech Co.,Ltd

91330523MA2B3WE119

CE

COVID19 IgG IgM Rapid Test Kit
COVID-19 Antigen Rapid Test

191

正元盛邦（天津）生物科技有限公司
JOYSBIO (Tianjin) Biotechnology Co., Ltd.

91120116553445456F

CE

COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
SARS-CoV-2 IgG/Neutralizing antibody Rapid Test Kit (Colloidal Gold)
SARS-CoV-2 Ag & Influenza Combo Rapid Test Kit (Colloidal Gold)
SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)

192

弗雷米德生物医药技术（天津）有限公司
FAMID Biomedical Technology (Tianjin) Co., Ltd.

911201163003152315

CE

COVID-19 IgG ELISA Kit
COVID-19 IgM ELISA Kit

193

天津森郁生物科技有限公司
Tianjin Seny Biotechnology Co.,Ltd.

91120113MA06GEEB7N

CE

SARS-COV-2 Total Antibody Test Kit (b-ELISA)
SARS-CoV-2 IgM Antibody Test kit (ELISA)
SARS-CoV-2 (2019-nCoV) Nucleoprotein ELISA Kit

194

上海宝藤生物医药科技股份有限公司
Shanghai Biotecan Pharmaceuticals Co.,Ltd.

91310000680954835B

CE

Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR)
SARS-CoV-2 IgM/IgG Rapid Test by Colloidal Gold Method

195

上海速创诊断产品有限公司
Shanghai Igenetec Diagnostics Co., Ltd

91310115MA1H76E24D

CE

Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip)
SARS-CoV-2 IgM/IgG Ab Diagnostic Test kit (Colloidal Gold-Based)
SARS-CoV-2 IgG Ab Diagnostic Test kit(Microfluidic immunofluorescence)
SARS-CoV-2 IgM Ab Diagnostic Test kit(Microfluidic immunofluorescence)
SARS-CoV-2 Ag Diagnostic Test kit(Microfluidic immunofluorescence)
Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR)

196

上海透景生命科技股份有限公司
Tellgen Corporation

91310000756110429R

CE

SARS-CoV-2 Nucleic acid detection kit based on Real-Time PCR platform
SARS-CoV-2 Nucleic acid detection kit Based on Cartridge Real-Time PCR platform
SARS-CoV-2 IgG Antibody Detection kit based on chemiluminescence Immunoassay platform
SARS-CoV-2 IgM Antibody Detection kit based on chemiluminescence Immunoassay platform
Swab Transport Medium (Modified Hank's buffer)
Swab Transport Medium (Modified Lysis buffer)
Nucleic acid extraction kit
SARS-CoV-2 Nucleic acid detection kit Based on Cartridge Real-Time PCR platform - N gene and ORF1ab gene

197

上海之江生物科技股份有限公司
Shanghai ZJ Bio-Tech Co., Ltd

913100007743014560

CE

Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit
Novel Coronavirus (SARS-CoV-2) Antigen and Antibody Assay kit
Liferiver Influenza and COVID-19 Real Time Multiplex RT-PCR Kit

198

上海长岛抗体诊断试剂有限公司
Shanghai Long Island Antibody Diagnostica Inc.

91310120631760815Y

CE

COVID-19 IgG/IgM Rapid Test (Colloidal Gold)

199

北京晋祺生物科技有限公司
Beijing Biogench Biotechnology Co., Ltd.

911101150896075290

CE

SARS-CoV-2 Nucleic Acid Detection Kit based on Real-time PCR Platform

200

北京尚精光电技术有限公司
Beijing Share-Sun Oet.Co.,Ltd

911101088013930941

CE

New coronavirus (SARS-CoV-2) antibody detection kit (colloidal gold method)

201

北京新兴四寰生物技术有限公司
Bioneovan Co., Ltd

91110115780996071X

CE

Diagnostic Kit for IgM Antibody to 2019-nCoV (Colloidal Gold)
Diagnostic Kit for IgG Antibody to 2019-nCoV (Colloidal Gold)
Diagnostic Kit for IgM/IgG Antibody to 2019-nCoV (Colloidal Gold)
COVID-19 Antigen Test Kit (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)

202

北京源景泰科生物科技有限公司
Beijing Origingene-Tech Biotechnology Co.,Ltd.

91110115MA01DFHH7R

CE

2019 Novel Coronavirus (2019-nCov) Nucleic Acid Detection Kit (PCR Fluorescence Probe Method)
SARS-CoV-2 IgM/IgG Antibody Rapid Assay Kit by Colloidal Gold Method

203

石家庄禾柏生物技术股份有限公司
Shijiazhuang Hipro Biotechnology Co.,Ltd

91130100794182204D

CE

2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold)
SARS-CoV-2 Neutralizing antibody Test Kit (Colloidal Gold)

204

江苏佰思瑞生物科技有限公司
Jiangsu Besthree Biotechnology Co., Ltd

91321291MA1MFTM181

CE

COVID-19 IgM/IgG Antibody Detection Kit（1 test/box、10 test/box）
New coronavirus (SARS-Cov-2) nucleic acid detection kit （25 tests/kit）
Nucleic Acid Isolation Kit(Magnetic Beeds Method) 250 tests/kit
Nucleic Acid Isolation Kit(Spin Column Method) 100 tests/kit
SARS-CoV-2 Rapid Ag Test (Colloidal Gold)

205

江苏默乐生物科技股份有限公司
Jiangsu Mole Bioscience Co.,Ltd.

91321291676365069L

CE

2019-Novel Coronavirus( ORF1ab, E & N genes) Nucleic Acid Test Kit (Fluorescent Probe-based Real-Time PCR assay)
A RAPID IgM-IgG Combined Antibody Test Kit for SARS-CoV-2 （ICA）
2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR Assay)
SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen)
SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit
SARS-CoV-2 Total Antibody Test Kit (ELISA)
SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)
Flu A/B + COVID-19 Antigen Combo Test Cassette Kit
SARS-CoV-2 Total Antibody Rapid Test Kit
SARS-CoV-2 Neutralization Antibody Rapid Test Kit
2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)

206

江苏三联生物工程有限公司
Jiangsu Sunlant Bioengineering Co.,Ltd

91320214661346893C

CE

Detection Kit for Novel Coronavirus(2019-nCoV)Total Antibody(ELISA)
Detection Kit for Novel Coronavirus(2019-nCoV) IgM and Total Antibody(Microarray Chemiluminescent Immunoassay)

207

瑞莱生物科技江苏有限公司
ReLIA Biotechnologies (Jiangsu), Inc.

9132129156683256XH

CE

Diagnostic Kit for Novel Coronavirus (SARS-CoV-2 ) IgM/IgG Antibody(Colloidal Gold) 
Diagnostic Kit for Novel Coronavirus (SARS-CoV-2 ) Antigen (Colloidal Gold)

208

苏州华益美生物科技有限公司
Bacme BioTech Co.,Ltd.

9132058557948658XY

CE

Novel Coronavirus (SARS-CoV-2) RNA Real-Time Kit (PCR- Fluorescence)
SARS-CoV-2 IgM/IgG detection kit (colloidal gold method)
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)

209

山东赫兹生物科技有限公司
Shandong H&Z Life Science Company Limited

91370600MA3MYFLP73

CE

Anti-COVID-19 virus IgM/IgG test kit (lateral flow assay)

210

潍坊市康华生物技术有限公司
Weifang Kanghua Biotech Co.,Ltd.

91370700266827355D

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test

211

合肥卡迪生物药业有限公司
Hefei Kadi Biological Pharmaceutical Co.,Ltd

913401223227499708

CE

COVID-19 IgG Rapid Test Kit(Colloidal Gold)
COVID-19 IgG/IgM Rapid Test Kit(Colloidal Gold)
COVID-19 IgM Rapid Test Kit(Colloidal Gold)

212

河北精硕生物科技有限公司
Hebei GenSure Biotech Inc.

91130182MA082NNG5P

CE

GenSureTM COVID-19 IgM Rapid Test
GenSureTM COVID-19 IgG/IgM Rapid Test
GenSure COVID-19 Antigen Rapid Test Kit
COVID-19/Flu A/B Antigen Combo Rapid Test

213

安徽恩禾生物技术有限公司
Anhui Enhe Biotechnology Co.,Ltd

91340100MA2QQ1EWX2

CE

SARS-CoV-2 IgM/IgG Test Kit
(Immunochromatographic Assay)

214

江西英大生物技术有限公司
Jiangxi Leandia Biotechnology Co.，Ltd

91360902MA35FX682L

CE

SARS-CoV-2 IgG/IgM antibody detection kit (colloidal gold immunochromatography)

215

青岛海诺生物工程有限公司
Qingdao Hainuo Biological Engineering Co. , Ltd

913702857180717488

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test (Immunochromatography)
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR)

216

山东博科生物产业有限公司
Biobase Biodustry（Shandong）Co., Ltd.

9137018179889855X7

CE

2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold)

217

江西业力医疗器械有限公司
Jiangxi Yeli Medical Apparatus co.,Ltd

913601113520833809

CE

Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing)
Detection Kit for 2019-nCoV Antibody (Colloidal Gold Immunochromatographic Method)
Detection Kit for 2019-nCoV Antibody (Quantum Dot Beads Immunochromatographic Method)

218

青岛浩铂生物科技有限公司
Qingdao Hydro Biotech. Co., Ltd.

91370212MA3C70W13F

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test
(Immunochromatography)
SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification)

219

青岛简码基因科技有限公司
Qingdao Jianma Gene Technology Co., Ltd.

91370222MA3P7FU64A

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method)

220

北京丹大生物技术有限公司
Beijing Diagreat Biotechnologies Co., Ltd

911101120716743951

CE

2019-nCoV IgG Antibody Determintation Kit
2019-nCoV IgM Antibody Determintation Kit
2019-nCoV IgG/IgM Antibody Rapid Test Kit (Colloidal gold Assay)
2019-nCoV specific test
2019-nCoV Antigen Rapid Test Kit (Colloidal gold Assay)

221

北京豪迈生物工程股份有限公司
Beijing Homa Biological Engineering Co., Ltd.

911101016000459665

CE

COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatographic Assay)
COVID-19 Antigen Test Kit (Colloidal Gold Immunochromatographic Assay)

222

安徽安科生物工程（集团）股份有限公司
Anhui Anke Biotechnology(Group) Co., Ltd.

91340100149030777L

CE

SARS-CoV-2(COVID-19)IgM/IgG Antibody Fast Detection Kit(Colldidal Gold)

223

安徽安龙基因科技有限公司
Anhui Anlong Gene Technology Co., Ltd.

91340100MA2N0B5J90

CE

Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR)

224

北京北方生物技术研究所有限公司
Beijing North Institute of Biotechnology Co., Ltd.

91110106101170666F

CE

COVID-19 IgG/IgM  Rapid Test
COVID-19 Antigen Rapid Test
SARS-CoV-2 Ab Detection ELISA Kit
SARS-CoV-2-S1 Ab Detection ELISA Kit
SARS-CoV-2-S1 Ab Rapid Test
SARS-CoV-2-NP Ab Rapid Test

225

北京泛生子基因科技有限公司
Genetron Health（Beijing）Co.,Ltd.

91110114339802512K

CE

Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing)

226

北京华科泰生物技术股份有限公司
Beijing Savant Biotechnology Co., Ltd.

9111010679755822XC

CE

New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)

227

北京祥瑞生物制品有限公司
Beijing Sanroad Biological Products Co.,Ltd    

911101161029817358

CE

Coronavirus Disease 2019 (COVID-19) Real-Time RT-PCR Diagnostic Kit
Coronavirus disease 2019 (COVID-19) IgG/IgM Antibody Rapid Test
( Colloidal-Gold Immunochromatographic Assay)

228

北京新基永康生物科技有限公司
Beijing Newglife Biotechnology Co., Ltd.

911103025891416069

CE

COVID-19 IgM/IgG Rapid Test
SARS-CoV-2 Nucleic Acid Detection Kit based on Real-time PCR Platform

229

同昕生物技术（北京）有限公司
Tarcine BioMed Inc.

91110114780951033E

CE

2019-nCoV IgG/IgM Antibody Rapid Test (Immunochromatography)
2019-nCoV IgM ELISA Kit
2019-nCoV IgG ELISA Kit

230

万华普曼生物工程有限公司
 W.H.P.M Bioresearch & Technology Co., Ltd.

91110105625911031F

CE

COVISURE COVID-19 IgM/IgG Rapid Test (Colloidal Gold Immuno-chromatography)

230

万华普曼生物工程有限公司
 W.H.P.M Bioresearch & Technology Co., Ltd.

91110105625911031F

CE

COVISURE COVID-19 IgM/IgG Rapid Test (Colloidal Gold Immuno-chromatography)
First Sign® SARS-CoV-2 Antigen Test

231

中生北控生物科技股份有限公司
BioSino Bio-Technology And Science Inc.

9111000010194414XN

CE

SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
SARS-CoV-2 Antigen Detection Kit (Colloidal gold Immunochromatographic Assay)

233

泰州泽成生物技术有限公司
Taizhou Zecen Biotech Co., Ltd.

913212910941159086

CE

SARS-CoV-2 IgG/IgM Rapid Test Cassette （20T, 50 T, 100 T, 200T）
COVID-19 IgG ELISA Kit (96T)
COVID-19 IgM ELISA Kit (96T)
SARS-CoV-2 IgG Detection Kit (CLIA) (24T, 50T, 100T, 200T)
SARS-CoV-2 IgM Detection Kit (CLIA) (24T, 50T, 100T, 200T)

234

艾康生物技术（杭州）有限公司
Acon Biotech (Hangzhou) Co., Ltd.

913301006091684447

CE

SARS-CoV-2 IgG/IgM Rapid Test
Foresight SARS-COV-2 IgG EIA Test Kit
Foresight SARS-COV-2 IgM EIA Test Kit
Promotor SARS-COV-2 RT-PCR Test Kit
Flowflex SARS-CoV-2 Antigen Rapid Test
SARS-CoV-2 Antigen FIA

235

杭州浙大迪迅生物基因工程有限公司
Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.

91330108757206959N

CE

COVID-19 IgG/IgM Rapid Test Kit
Influenza A+B/ COVID-19 Antigen Rapid Test Device
SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab)
SARS-CoV-2 Neutralizing Antibody Test Kit
SARS-CoV-2 Neutralizing Antibody Rapid Test Kit

236

浙江安宁生物科技有限公司
Higene Incorporation

913304110959769105

CE

Novel coronavirus (SARS-CoV-2) nucleic acid detection Kit (Fluorescence quantitative RT-PCR)

237

湖南润美基因科技有限公司
Hunan Runmei Gene Technology Co., Ltd.

91430105MA4PJ2NG30

CE

New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent RT-PCR Method)
New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold)
SARS-CoV-2 (COVID-19) IgG Antibody  Detection Kit (ELISA)
SARS-CoV-2 (COVID-19) IgM Antibody  Detection Kit (ELISA)
SARS-CoV-2 (COVID-19) Neutralizing Antibody Detection Kit (ELISA)

238

圣湘生物科技股份有限公司
Sansure Biotech Inc.

91430100673566826X

CE

Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Multi-type Sample DNA/RNA Extraction-Purification Kit (magnetic beads method)
(S1005E)
Multi-type Sample DNA/RNA Extraction-Purification Kit (magnetic beads method)
Sample Storage Reagent
SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)
SARS-CoV-2 Rapid Antigen Test (Colloidal Immunization Method)
SARS-CoV-2 Antigen Sealing Tubular Test (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Novel Coronavirus (SARS-CoV-2) Respiratory Pathogens Multiplex Panel Nucleic Acid Diagnostic Kit (PCR Fluorescense Probing)
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR - Fluorescence Probing)
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

239

艾博生物医药（杭州）有限公司
ABON Biopharm (Hangzhou) Co., Ltd.
（持证公司：Abbott Rapid Diagnostics Jena GmbH ）

91330100747181663M

CE

PanbioTM COVID-19 IgG/IgM Rapid Test Device
Panbio COVID-19 Ag Rapid Test Device

240

珠海市丽拓生物科技有限公司
Zhuhai Lituo Biotechnology Co.,Ltd

9144040072506014X8

CE

COVID-19 IgG/IgM Detection Kit （Colloidal Gold）
COVID-19 Antigen Detection Kit(Colloidal Gold)
COVID-19 Antigen Detection Kit(Immunofluorescence Assay)

241

深圳博识诊断技术有限公司
Shenzhen BOSH Diagnostics, Ltd.

9144190005678385XB

CE

SARS-CoV-2 IgM & IgG Rapid Test

242

深圳市比特科技有限公司
BCT Systems Co., Ltd.

914403007412434137

CE

One Step Novel Coronavirus (COVID-19) Test (Immunochromatography Assay)

243

珠海赛乐奇生物技术股份有限公司
Zhuhai Sinochips Bioscience Co.,Ltd.

91440400779214933J

CE

COVID-19 Nucleic Real-time PCR Test Kit

244

佳贺斯（浙江）生物医药科技有限公司
Famyhealth(zhejiang) Biomedical Technology Co., Ltd

9133042MA12CXTA20U

CE

Novel Coronavius(2019-nCoV) IgM/IgG Antibody Diagnostic kit (Urine sample)(Colliodal Gold)

245

广州阳普医疗科技股份有限公司
Guangzhou Improve Medical Instruments Co.,Ltd.

91440101618681696W

CE

SARS-CoV-2 Test Kit（Real-time PCR）

246

深圳真瑞生物科技有限公司
Shenzhen Zhenrui Biotech Co.,Ltd
（持证公司: Multibrands International Ltd）

91440300073368586N

CE

Covid-19 (SARS-Cov-2) IgG/IgM GICA rapid test (Colloidal Gold)

247

迪亚莱博（张家港）生物科技有限公司
Dialab ZJG Biotech Co.Ltd.

91320592MA1MXRQC6X

CE

SARS-CoV-2 IgG/IgM antibody Test
(Fluorescence Immunoassay)

248

江苏凯基生物技术股份有限公司
Jiangsu KeyGEN BioTECH Co.,Ltd

91320100726059546Q

CE

(2019-nCoV IgM/IgG antibody （whole blood/serum/plasma） detection kit
Influenza A+B/COVID-19 Antigen Combined Rapid Test Kit （Colloidal Gold Method）
COVID-19 Antigen Rapid Test Kit （Colloidal Gold Method）

249

南京申基医药科技有限公司
Nanjing Synthgene Medical Technology Co., Ltd.

91320114MA1X09DE0U

CE

SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)
COVID-19 IgM/IgG Antibody Rapid Detection Kit(Colloidal gold method)
SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)

250

绍兴迅敏康生物科技有限公司
Shaoxing XunMinKang Biotechnology Inc

91330600097837658F

CE

Real-time PCR Kit for Rapid Detection of 2019-nCoV

251

江苏宜偌维盛生物技术有限公司
Innovation Biotechnology Co., Ltd. Jiangsu

91320118084172255Q

CE

Novel Coronavirus (SARS-CoV-2) IgG / IgM Antibody Test Kit (Immunochromatography)
Novel Coronavirus（SARS-CoV-2）Neutralizing Antibody Test Kit (Immunochromatography)
New coronavirus (SARS-CoV-2) antigen detection kit (immunochromatography)

252

上海锐翌生物科技有限公司
Shanghai Realbio Technology Co.,Ltd.

9131011531252759XP

CE

2019-novel coronavirus (2019-nCoV) Nucleic Acid Assay Kit (Fluorescence PCR Method)

253

内蒙古因诺生物技术有限公司
Inner Mongolia Biotechnology Co.,Ltd

91150402MA0N1RGX9D

CE

DNA & RNA Sample Collection Kit
Viral Transport Medium
Viral DNA/RNA Extraction Kit (Magnetic Bead Method)
SARS-CoV-2 RT-qPCR Fluorescence Detection Kit (ORF1ab, N&E Genes)

254

上海纳奥生物科技有限公司
Shanghai Focusgen Biotechnology Co. Ltd.

91310113MA1GNTTTXW

CE

Novel coronavirus (2019-nCoV) Real-time PCR kit
Influenza Virus and SAS­CoV­2 Multiplex Direct RT­PCR Test Kit
SAS-CoV-2-IgG/IgM Antibody Rapid Test Device (Immunochromatography)

255

天津喜诺生物医药有限公司
Genobio Pharmaceutical Co., Ltd.

911201160937317765

CE

COVID-19 IgM Lateral Flow Assay
COVID-19 IgG Lateral Flow Assay

256

杭州丹威生物科技有限公司
Hangzhou Danwei Biotechnology Co., Ltd.

91330110328281926J

CE

2019-nCoV Direct qPCR Kit
SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)
SARS-CoV-2 Detection Kit (Direct Fluorescence PCR)
SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR)
SARS-CoV-2 K417N/E484K Mutations Detection Kit (Fluorescence PCR)
SARS-CoV-2 N501Y/HV69-70del Mutations Detection Kit (Fluorescence PCR)

257

北京卓诚惠生生物科技股份有限公司
Beijing Applied Biological Technologies Co., Ltd.

91110114556887989H

CE

Multiple Real-Time PCR Kit for Detection of 2019-nCoV

258

佰奥达生物科技（武汉）股份有限公司
Bioda Diagnostics(Wuhan)Co.,Ltd

914201005848907982

CE

Novel Coronavirus (COVID-19) Antibody IgM/IgG Test (Colloidal gold)
Novel Coronavirus (COVID-19）Antigen Test Kit (Colloidal Gold)

259

长春万成生物电子工程有限公司
ChangChun WanCheng Bio-Electron Co.,Ltd

91220101730782892X

CE

COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT(Colloid Gold Immunochromatography)
COVID-19 Antigen Rapid Test Kit (Colloidal gold immunochromatography)

260

上海凯璟生物科技有限公司
Shanghai Cagenbio Science Co., Ltd.                 

91310117069329429N

CE

COVID-19 IgG/IgM Rapid Test (Later Flow Assay)
COVID -19 Nucleic Aicd Kits (Fluorescence RT-PCR)
COVID-19 NP Rapid Test Kits (Lateral Flow Assay)
COVID-19/Influenza A+B Antigen Test Kit (Lateral Flow Assay)

261

百康芯（天津）生物科技有限公司
Baicare （Tianjin）Biotechnology Co.,Ltd

91120222MA05JJAU6D

CE

SARS-CoV-2 Real Time RT-PCR Kit
SARS-CoV-2 IgG/IgM Rapid Test

262

天津金匙医学科技有限公司
Tianjin Genskey Medical Technology Co., Ltd.

91120222MA06AJBX93

CE

GensKey SARS-CoV-2 IgM/IgG Rapid Test
GensKey SARS-CoV-2 RT-PCR Kit
GensKey SARS-CoV-2 Sequencing Assay

263

天津瑞爱金生物科技有限公司
Tianjin Reagent Biotech Co., Ltd.

911201167548491904

CE

SARS-COV-2 total IgM/IgG antibody detection kit (colloidal gold method)

264

杭州安旭生物科技股份有限公司
Assure Tech. (Hangzhou) Co., Ltd.
(持证公司：Azure Biotech Inc )

913301066767726252

CE

COVID-19 IgG/IgM Rapid Test Device
COVID-19 Antigen Rapid Test Device

265

杭州安旭生物科技股份有限公司
Assure Tech. (Hangzhou) Co., Ltd.
(持证公司：Nal Von Minden GmbH )

913301066767726252

CE

COVID-19 lgG/lgM Test
COVID-19 Ag Test

266

青岛复诺生物医疗有限公司
Qingdao Funuo BioMedical Co., Ltd.

91370212MA3Q3M328R

CE

COVID-19 Multiplex Fluorescent PCR Kit

267

杭州奥泰生物技术股份有限公司
Hangzhou Alltest Biotech Co.,Ltd

91330101685842840Y

CE

Infection Disease Rapid Tests：
1、2019-nCoV (Novel Coronavirus) IgG/IgM Rapid Test Cassette (INCP-402)
2、2019-nCOV (Novel Coronavirus) IgG/IgM Rapid Test Cassette Single use kit (INCP-402S)
COVID-19 IgG/IgM Rapid Test
COVID-19 (Novel Coronavirus) IgG Rapid Test (Cassette) INCPG-402,
COVID-19 (Novel Coronavirus) IgG Rapid Test (Strip) INCPG-411,
COVID-19 (Novel Coronavirus) and M.pneumoniae IgG/IgM Combo Rapid Test Cassette INMC-425
COVID-19 (Novel Coronavirus) and M.pneumoniae IgG Combo Rapid Test (Cassette) INMCG-425
SARS-COV-2 RT-qPCR Assay
COVID-19 Antigen Rapid Test
COVID-19 and Influenza A+B Antigen Combo Rapid Test
COVID-19 (Novel Coronavirus) IgG/IgM Rapid Test (Cassette) (For Reader) INCP-R402
COVID-19 (Novel Coronavirus) Antigen Rapid Test (Cassette) (For Reader) INCP-R502
COVID-19 (Novel Coronavirus) IgG/IgM Test Cassette (For Analyzer) FI-NCP-402
COVID-19 (Novel Coronavirus) Antigen Test Cassette (For Analyzer) FI-NCP-502
COVID-19 Antigen Rapid Test (Oral Fluid)
COVID-19 Antigen Rapid Test Strip
SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test
SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae  Antigen Combo Rapid Test
COVID-19 IgG/IgM and Antigen Combo Rapid
SARS-CoV-2 Antigen Rapid Test INCP-502

268

杭州普望生物技术有限公司
Hangzhou Proprium Biotech Co.Ltd

91330100560586994D

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit

269

北京倍肯恒业科技发展股份有限公司
Beijing Biochem Hengye Science & Technology Development Co., Ltd.

9111011475468551X8

CE

SARS-CoV-2 Real-Time RT-PCR Kit
SARS-CoV-2 Antibody Test Kit (Collide Gold based Lateral Flow Method)

270

广东国盛医学科技有限公司
Guangdong Ardent Biomed Co., Ltd.

91440101MA59C9LH7J

CE

Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)

271

广东和信健康科技有限公司
Guangdong Hecin Scientific, Inc.

914401013314972504

CE

COVID-19 Real-time PCR Assay Kit
COVID-19 Antigen Test Kit (colloidal gold method)
2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)
2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)
COVID-19 IgG Antibody Test Kit (colloidal gold method)

272

广州市达瑞生物技术股份有限公司
Guangzhou Darui Biotechnology Co.,Ltd.

91440101751998561Y

CE

SARS-Cov-2 IgG Antibody Detection Kit (Colloidal Gold )
SARS-Cov-2 IgG Antibody Detection Kit (ELISA )
SARS-Cov-2 IgM Antibody Detection Kit (Colloidal Gold )
SARS-Cov-2 IgM Antibody Detection Kit (ELISA )

273

深圳生科原生物有限公司
Mabsky Bio-Tech Co., Ltd.

91440300766381820U

CE

COVID-19 virus(2019-nCoV) Dual-Detection Kit (Real-Time PCR Method)
COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR Method)
Influenza A virus; Influenza B virus&COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR
Method)
Influenza A virus, Influenza B virus, COVID-19 virus (2019-nCoV) & Respiratory syncytial virus Quadruple-Detection Kit (Real-Time PCR Method)

274

江苏麦得科生物科技有限公司
Jiangsu MDK Biotech Co.,Ltd.

91321322MA1MD5TM82

CE

2019-nCoV IgG/IgM antibody rapid test cassette (Immunochromatographic Assay)

275

百沃特（天津）生物技术有限公司
Biovet Biotech Ltd

91120222MA06Y7AU6D

CE

Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (RT-PCR Fluorescence Probing)

276

江西千分生物科技有限公司
Precisionist Diagnostics Co.,Ltd.

913605043147339609

CE

2019-nCoV IgM/IgG Rapid Test Kit

277

苏州鼎实医疗科技有限公司
Suzhou Topmedlab Medical Science And Technology Co.,Ltd.

91320505331218709T

CE

(COVID-19)IgG/IgM Rapid test kit (dyed microspheres )

278

博奥赛斯（天津）生物科技有限公司
Bioscience (Tianjin) Diagnostic Technology Co.,Ltd.

911201105503844910

CE

Novel Coronavirus (2019-nCoV) Antibody Rapid Test
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test
Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
Novel Coronavirus (2019-nCoV) Antigen Rapid Test
Novel Coronavirus (2019-nCoV) Neutralizing Antibody Rapid Test
Novel Coronavirus (2019-nCoV) Neutralizing Antibody Diagnostic Kit

279

云南瑞栢泰生物科技有限公司
Yunnan Rare Biotechnology Co.,Ltd.

91530100MA6K9HK841

CE

COVID-19 Nucleic Acid Detection Kit (Fast Real-Time PCR)

280

北京康思润业生物技术有限公司
Beijing O&D Biotech Co.,Ltd.

91110113743312865R

CE

Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold)
COVID-19 IgM/IgG Rapid Test
COVID-19 Antigen Rapid Test

281

武汉康德庆生物科技有限公司
Wuhan KangDeQing Biotechnology Co., Ltd.

914201005584269915

CE

2019 New Coronavirus (2019n-CoV) IgM/IgG Antibody Test Kit (Colloidal Gold)
2019-New Coronavirus (COVID-19) Antigen Rapid Test Kit (Colloidal Gold)

282

北京岱美仪器有限公司
Beijing DiagMed Instrument Co., Ltd.

91110115MA0030NY8A

CE

COVID-19 virus (2019-nCoV) Detection Kit (Multiplex Real-Time PCR)

283

泰普生物科学（中国）有限公司
Triplex International Biosciences(China) Co.,Ltd

91350200751630628A

CE

SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold)
SARS-CoV-2 Nucleic Acid Detection Kit (RT-PCR Fluorescence Probing Method)
SARS-CoV-2 Antigen Rapid Test Kit

284

凯之迪（重庆）医疗科技有限公司
Kaizhidi (Chongqing) Medical Technology Co., Ltd.

91500116MA60QNNJ4D

CE

Diagnostic Kit for novel coronavirus (SARS-CoV-2) lgM & lgG Antibody (Colloidal Gold)

285

重庆威斯腾生物医药科技有限责任公司
Chongqing Western Biomedical Technology Co., Ltd.

91500107305135838P

CE

Nucleic Acid Detection Kit for Novel Coronavirus (COVID-19) One-Step Taqman qPCR

286

重庆业为基生物科技有限公司
Chongqing Novegent Biotech Co.,Ltd

91500107563474760J

CE

COVID-19 Coronavirus IgM/IgG Antibody Rapid Test Kit(Colloidal Gold)
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

287

云奥生物科技（常州）有限公司
Riogene Biotech (Changzhou) Co.,Ltd.

91320411MA1WBG6504

CE

COVID-19 I9M/IgG Antibody Detection Kit (Colloidal Gold)

288

江苏汇先医药技术有限公司
Hemosmart Medical Technology Limited

91320583MA1X9GHC84

CE

New coronavirus SARS-CoV-2 nucleic acid detection kit (multiplex fluorescence PCR)

289

厦门集庆生物医药科技有限公司
Xiamen Jiqing Biomedical Technology Co., Ltd

91350205303182171J

CE

Novel coronavirus COVID-19 IgM/IgG detection kit (colloidal gold method)
Novel coronavirus COVID-19 IgM detection kit (colloidal gold method)
Nucleic Acid Extraction Kit
Novel Coronavirus (2019-nCOV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes)
SARS-CoV-2 Antigen Dectiont Kit (Colloidal Gold Method)

290

郑州方欣生物科技有限责任公司
Zhengzhou Fortune Bioscience Co.,Ltd．

9141012275515522X1

CE

COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
SARS-CoV-2 RT-qPCR Fluorescence Detection Kit (ORF1ab & N Genes)
SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
COVID-19 Antigen Rapid Test Cassette (Swab)
COVID-19 And Influenza A/ influenza B virus Antigen Combined Test Cassette (Swab)
Saliva COVID-19 Antigen Test Kit

291

郑州人福博赛生物技术有限责任公司
Zhengzhou Humanwell Biocell Biotechnology Co., Ltd

914101001700496910

CE

BIOCELL COVID-19 IgM ELISA Kit
BIOCELL COVID-19 IgG ELISA Kit

292

凡知医疗科技（江苏）有限公司
Firegen Biomedicals (Jiangsu) Co.,Ltd.

91320583MA1WXQHG8A

CE

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescence PCR Method)
Novel Coronavirus (SARS-CoV-2) lgM/lgG Antibody Detection Kit (Colloidal Gold-Based)

293

博奥赛斯（重庆）生物科技有限公司            Bioscience(Chongqing) Diagnostic Technology Co.,Ltd.

91500105MA60HMMHXQ

CE

Novel Coronavirus (2019-nCoV) Antibody Rapid Test
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test
Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
Novel Coronavirus (2019-nCoV) Neutralizing Antibody Diagnostic Kit (MCLIA)

294

苏州天隆生物科技有限公司
Suzhou Tianlong Bio-Technology Co., Ltd.

91320594699344092G

CE

Novel Coronavirus(2019-nCoV) Nucleic Acid Detection Kit
SARS-CoV-2 Nucleic Acid Detection Kit (Real-time RT-PCR Method)
SARS-CoV-2 Nucleic Acid Multiplex Detection Kit (Real-time RT-PCR Method)

295

湖北金鉴生物有限公司
Hubei Jinjian Biology Co.Ltd.

91421200MA49AY5T9R

CE

2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold Method)
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)
Novel Coronavirus Neutralizing Antibody Test Kit (Colloidal Gold Method)

296

杭州德同生物技术有限公司
Hangzhou Dalton BioSciences, Ltd.

913301086970931707

CE

COVID-19 IgM/IgG Rapid Combined Antibody Test (ICA)

297

高碑店市普瑞赛斯生物科技有限公司
Gaobeidian PRISES Biotechnology Co., Ltd

91130684592498649Y

CE

COVID-19 IgG/IgM Test (Colloidal Gold)

298

尼沃诺斯（苏州）生物工程有限公司
Neo-Nostics (Suzhou) Bioengineering Co., Ltd.

913205853392643554

CE

2019nCoV IgG/IgM Antibody Test Kit (Colloidal Gold Method）
COVID 19 Antigen Test Kit (Colloidal Gold Method)

299

无锡中德伯尔生物技术有限公司
Wuxi Zodolabs Biotech Co.,Ltd

91320206665794896E

CE

SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal Gold Immunochromatography)

300

上海芯超生物科技有限公司
Shanghai Outdo Biotech Co.,Ltd.

91310000757589048R

CE

Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test
Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test (Colloidal Gold)

301

浙江东方基因生物制品股份有限公司
Zhejiang Orient Gene Biotech Co., Ltd.
（持证公司：Healgen Scientific LLC）

913305007804719612

U.S. FDA EUA

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

302

广州合尔拓生物科技有限公司
Co-Innovation Biotech Co.Ltd

91440106591544869L

CE

One Step 2019-Novel Coronavirus (2019-nCoV) IgG/IgM Test Cassette
One Step 2019-Novel Coronavirus (2019-nCoV)  Antigen Test Cassette

303

广州奇辉生物科技有限公司
GenePhar Technologies Co. Ltd.（GZ）

91440101331479845K

CE

Multiplex Real-time RT-PCR Kit for Detection SARS-CoV-2 Nucleic Acid，Nucleic Acid Isolation Kit

304

深圳市汇松科技发展有限公司
Shenzhen Huisong Technology Development Co.,Ltd

914403007798955807

CE

COVID-19 IgG/IgM Antibody Combo Rapid Test（Colloidal Gold）

305

深圳市真迈生物科技有限公司
GeneMind Biosciences Company Limited

914403005990671472

CE

GeneMind Real-time SARS-CoV-2 Test Kit

306

珠海辉睿生物科技有限公司
Zhuhai Huirui Biotechnology Co.Ltd.

91440404MA54BDY875

CE

COVID-19 ORF1ab/N Gene Fluorescent PCR Detection Kit

307

深圳蓝韵生物技术有限公司
Shenzhen Landwind Biotechnology Co.,Ltd  

 914403003591606257

CE

Novel Coronavirus(2O19-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
SARS-CoV-2 Antigen Test Kit(Colloidal Gold),
Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit

308

深圳雷杜生命科学股份有限公司
Rayto Life and Analytical Sciences Co., Ltd.

91440300734144070J

CE

Novel CoronaVirus IgM Antibody (2019-nCoV IgM) Reagent Kit (Chemiluminescent Immunoassay)
Novel CoronaVirus IgG Antibody (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)

309

深圳褀氏生物科技有限公司
Shenzhen Kisshealth Biotechnology Co., Ltd.

91440300MA5FATQ09L

CE

Severe Acute Respiratory Syndrome Coronavirus 2（SARS-CoV-2）IgM/IgG Antibody Test Kit（Immunochromatography）
Syndrome Coronavirus 2（SARS-CoV-2）Antibody Test Kit（Latex particle-enhanced turbidimetric immunoassay）
SARS-CoV-2 Antigen Test Kit (GICA)
SARS-CoV-2/Human Influenza Virus A&B(Flu A&B)Antigen Test Kit (Colloidal Gold)
SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)

310

深圳市华科瑞科技有限公司
Shenzhen Highcreation Technology Co.,Ltd

914403007883039467

CE

Novel Coronavirus IgM/IgG Combo Rapid Test

311

深圳市雷诺华科技实业有限公司
Labnovation Technologies, Inc.

91440300728579078P

CE

COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit
(Immunochromatography Assay)
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)
SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit (Immunochromatography)

312

深圳市芯思微生物科技有限公司
Singuway Biotech Inc.

91440300MA5EMB7P8Y

CE

COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
Detection Kit For Coronavirus Disease 2019(COVID-19)(PCR Fluorescence Probe)
COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)

313

英诺生物技术（深圳）有限公司
Immunodiagnostics (Shenzhen) Biotech limited 

91440300MA5G0G9K5K

CE

SARS-CoV-2 NP Ab ELISA kit
SARS-CoV-2 NP IgG ELISA kit
SARS-CoV-2 NP IgM ELISA kit

314

广州安必平医药科技股份有限公司
Guangzhou LBP Medicine Science & Technology Co.,Ltd.

914401017756768239

CE

SARS-COV-2 viral RNA detection kit (real-time RT-PCR method)

315

上海五色石医学科技有限公司
Shanghai Medicore Technology Co., Ltd

91310120MA1HU09Y3H

CE

Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (Fluorescent PCR Method)

316

温州瓯佳生物科技有限公司
Wenzhou OJA Biotechnology Co., Ltd.

91330303MA2HC19B10

CE

Real-time PCR Kit for Rapid Detection of SARS-CoV-2
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)
Influenza A&B/SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)

317

重庆新赛亚生物科技有限公司
Chongqing iSIA BIO-Technology Co.,Ltd

91500000MA5U60006X

CE

Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence)
Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography)
Novel Coronavirus (2019-nCoV) IgM Test Kit (Colloidal Gold Immunochromatography)
Novel Coronavirus (2019-nCoV) IgG Test Kit (Colloidal Gold Immunochromatography)
SARS-CoV-2 Antigen Rapid Test Kit (Quantum Dots Immunofluorescence)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

318

武汉康昕瑞基因健康科技有限公司
Wuhan Considerin Gene&Health Technology Co., Ltd.

91420100079644043T

CE

COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Colloidal Gold)
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR)

319

北京泛生子基因科技有限公司
Genetron Health（Beijing）Co.,Ltd.

91110114339802512K

U.S. FDA EUA

Genetron SARS-CoV-2 RNA Test

320

北京易斯威特生物科技股份有限公司
Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd
（持证公司：Shandong H&Z Life Science Company Limited）

91110115755270009B

CE

Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay)

321

广东唯实生物技术有限公司
Guangdong Wesail Biotech Co., Ltd.

91441900MA548GY2XX

CE

Coronavirus COVID-19 IgM/IgG Test Kit
Coronavirus COVID-19 IgM Test Kit
Coronavirus COVID-19 IgG Test Kit
COVID-19 Ag Test Kit
FIu+COVID-19 Ag Test Kit
COVID-19 Neutralizing Antibody Test Kit

322

杭州比格飞序生物科技有限公司
Hangzhou Bigfish Bio-tech Co., Ltd.

91330108MA28UEWC1M

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR)

323

杭州博拓生物科技股份有限公司
Hangzhou Biotest Biotech Co.,Ltd

9133010079969193XF

U.S. FDA EUA

RightSign COVID-19 IgG/IgM Rapid Test Cassette

324

辽宁迈迪生物科技股份有限公司
Liaoning MEDI Biotechnology Co.,Ltd.

912105006837394950

CE

2019-nCoV (ORF1ab, E & N genes) Detection Kit (Fluorescent Probe-based Real-time PCR assay)

325

南通深澜生物科技有限公司
Nantong Shenlan Biotechnology Co., Ltd.

 91320611MA21G0XRX3

CE

COVID-19 IgG/IgM Antibody Test Kit（Colloidal Gold immunochromatographic)

326

上海捷门生物技术有限公司
Shanghai Jiemen Bio-Tech Co.,Ltd.

91310105132752810W

CE

2019-nCOV IgM/IgG Antibody Test Kit (Colloidal Gold)

327

上海仁度生物科技有限公司
Shanghai Rendu Biotechnology Co., Ltd.

91310115662456111U

CE

AmpSure® 2019-nCoV RNA Assay

328

温州市维日康生物科技有限公司
Wenzhou weirikang Biotechnology Co., Ltd.

91330304746330137P

CE

COVID-19 IgG/lgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

329

北京纳百生物科技有限公司
Ring Biotechnology Co Ltd

91110302317918055P

CE

COVID-19 IgM/IgG Rapid Test Kit

330

胡曼诊断产品（北京）有限公司
HUMAN Diagnostics Product(Beijing) Co.,Ltd.

91110302MA006XTA6E

CE

HEXAGON SARS-CoV-2 IgM-IgG

331

深圳容金科技有限公司
Shenzhen Reagent Technology Co.,Ltd.

914403006911615909

CE

COVID-19 lgG/lgM Rapid Test Kit
SARS-CoV-2 antigen IVD kit

332

湖南大地同年生物科技有限公司
Hunan Yearth Biotechnological Co., Ltd.

91430100MA4L5ERF32

CE

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

333

江苏维尔生物科技有限公司
Jiangsu Well Biotech Co., Ltd.

91320413796137618Y

CE

COVID-19 IgM/IgG Rapid Test (Colloidal Gold)
COVID-19 Ag Rapid Test
COVID-19 Ag Rapid SalivaTest Device

334

江苏扬新生物医药有限公司
EACHY Biopharmaceuticals Co., Ltd.

91320582067625902N

CE

AccuRapidTM SARS-CoV-2 IgM/IgG Test Kit
(Lateral Flow Immunoassay)
SARS-CoV-2 Antigen Rapid Test Kit

335

融智生物科技（青岛）有限公司
Intelligene Biosystms(QingDao)Co.Ltd

913702220773649614

CE

Seven Respiratory Virus Detection Kit (Real-Time RT-PCR Method)
Microfluidic Multiplex Real-Time Quantitative PCR Analyzer

336

艾康生物技术（杭州）有限公司
Acon Biotech (Hangzhou) Co., Ltd.
（持证公司：ACON Laboratories, Inc.）

913301006091684447 

CE

ACON® SARS-CoV-2 IgG/IgM Rapid Test
Promotor® SARS-CoV-2 RT-PCR Test Kit
Flowflex® SARS-CoV-2 Antigen Rapid Test
Foresight® SARS-CoV-2 IgG EIA Test Kit
Foresight® SARS-CoV-2 IgM EIA Test Kit
SARS-CoV-2 Antigen FIA

337

杭州麦伯生物技术有限公司
Hangzhou Magic Biotechnology Co.,Ltd.

91330106MA27WPXT7M

CE

Viral Nucleic Acid Extraction Kit
Viral Nucleic Acid Extraction Kit II

338

杭州遂曾生物技术有限公司
HangZhou Lifereal Biotechnology Co.,Ltd.

91330110396162830J

CE

COVID-19 nucleic acid (RNA) Detection kit (Real-time Fluorescent PCR method)
COVID-19 nucleic acid (RNA) POCT detection kit (AIGS real-time fluorescent PCR method)
2019-nCoV/Influenza A/Influenza B Nucleic Acid (RNA) POCT Detection Kit (AIGS real-time fluorescent PCR method)

339

诺迦（杭州）生物工程有限公司
New Gene (Hangzhou)  Bioengineering Co., Ltd.

91330108MA2H3RX57K

CE

COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold) (COVID-19-NG01)
Novel Coronavirus Antigen Detection Kit (Colloidal Gold) (COVID-19-NG02)
COVID-19 IgM/IgG Antibody Detection Kit (Quantum Dot Immunochromatography) (COVID-19-NG03)
Novel Coronavirus Spike Glycoprotein Detection Kit (Ligand-receptor Competitive Chromatography) (COVID-19-NG04)
Novel Coronavirus Ribonucleic Acid Detection Kit
COVID-19 Antigen Detection Kit
COVID-19 Antibody / Antigen Detection Kit
COVID-19 / Influenza A / Influenza B Detection Kit
COVID-19 Neutralizing Antibody Detection Kit
Novel Coronavirus Nucleocapsid Protein Detection Kit
COVID-19 Antibody Detection Kit

340

深圳市金准生物医学工程有限公司
Shenzhen Kingfocus Biomedical Engineering Co.,Ltd.

9144030008858306X1

CE

Novel Coronavirus (2019-nCoV) IgM / IgG antibody detection kit (AIE DOTS/Quantum Dots-Based Immunofluorescence Chromatography)

341

安徽华培生物科技有限公司
Anhui Hua Pei Biotechnology Co., Ltd

91340100MA2TRGPT4Y

CE

 COVID-19 Antigen Detection Kit (Fluorescence Immunochromatography Assay)

342

北京现代高达生物技术有限责任公司
Beijing Modern Gaoda Biotechnology Co.,Ltd.

911103026337763199

CE

Colloidal Gold Immunochromatography Detection Kit For Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody
Colloidal Gold Immunochromatography Detection Kit For Novel Coronavirus (SARS-CoV-2) Antigen

343

亚能生物技术（深圳）有限公司
Yaneng Bioscience (Shenzhen) Co., Ltd.

91440300728572933L

CE

COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR）

344

桂林优利特医疗电子有限公司
URIT Medical Electronic Co., Ltd.

9145030075651305XT

CE

IgM/IgG antibody assay reagent for novel coronavirus (immunochromatography)
Real-Time RT-PCR Detection of SARS-CoV-2 Kit (Real-Time RT-PCR Fluorescent Probe Method)

345

南京帝准生物科技有限公司
Nanjing DiaZoom Biotech Co., Ltd.
（持证公司：DiaCarta Inc.）

91320191MA1WEBGC40

CE

QuantiVirus™ Real-Time PCR Coronavirus SARS-CoV-2 Test Kit
QuantiVirus™ SARS-CoV-2 Multiplex Detection Test

346

苏州吉玛基因股份有限公司
Suzhou GenePharma Co., Ltd.

91320000666378931N

CE

SARS-CoV-2 nucleic acid detection Kit

347

山西康健恩生物科技有限公司
ShanXi Kangjianen Biotechnology Co.,Ltd.

91141000MA0K12T43J

CE

Diagnostic Kit for IgM/IgG 2in1 Antibody to 2019-nCoV (Colloidal Gold)

348

西安博睿康宁生物医学中心有限公司
Xi'an Bioreal-Coming BioMed Center.,Ltd.

91611103MA6TK7GY2X

CE

COIVD-19 Nucleic Acid Detection Kit (Fluorescence PCR Method)

349

新羿制造科技（北京）有限公司
TargetingOne Technology (Beijing) Corporation

91110114MA00ALRF3L

CE

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Digital PCR Method)
Nucleic Acid Extraction Reagent

350

必欧瀚生物技术（合肥）有限公司
Biohit Healthcare （Hefei）Co.,Ltd.

913401000822055000

U.S. FDA EUA

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

351

广州微远医疗器械有限公司
GZ Vision Medicals Instrument Co.,Ltd.

91440101MA5CKRDN0U

CE

SARS-CoV-2 Clinical Sequencing Assay
SARS-CoV-2 RT-PCR Assay
SARS-CoV-2 IgG/IgM Antibody Assay

352

梅州康立高科技有限公司
Meizhou Cornley Hi-Tech Co.,Ltd.

91441400756493482R

CE

COVID-19 IgG/IgM Dectection Kit(Colloidal Gold)

353

深圳天深医疗器械有限公司
Shenzhen Tisenc Medical Devices Co.,Ltd.

91440300335164330P

CE

2019 Novel Coronavirus IgG kit (CLIA)
2019 Novel Coronavirus IgM kit (CLIA)
SARS-CoV-2 Antigen (CLIA)
SARS-CoV-2 IgM/IgG Antibody Test Kit(Immunochromatography)
SARS-CoV-2 Antigen Test Kit(Immunochromatography)

354

深圳真瑞生物科技有限公司
Shenzhen Zhenrui Biotech Co.,Ltd.              

91440300073368586N

CE

SARS-Cov-2 RT-PCR
COVID-19 IgG/IgM Rapid Test Casette (WB/S/P)

355

河南维锐生物科技有限公司
Henan Wayray Biotech Co.,Ltd.

91410296MA442DX471

CE

COVID-19 IgM/IgG Rapid Test (Latex Immunochromatography)

356

武汉汇海医药科技发展有限公司
Wuhan Huihai Medicine  Technology Development  Co., Ltd.

91420105741413099Y

CE

2019-nCoV Antigen Rapid Test Kit (Colloidal Gold)

357

武汉纳达康生物科技有限公司
Wuhan NanoDiagnosis for Health Biotechnology Co.,Ltd.

9142010030368098X3

CE

SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method)
COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method)
COVID-19 Antigen Rapid Test Cassette (Colloidal Gold Method)
SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Colloidal Gold Method) 

358

江苏戴格诺思生物技术有限公司
Jiangsu Diagnostics Biotechnology Co.,Ltd.

91321291551185451D

CE

COVID-19 IgG/IgM Rapid  Test Cassette (WB/S/P)
COVID-19 Nucleic Acid Detection Kit (Fluorescent RT-PCR)
COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette（Colloidal Gold ）
COVID-19 Antigen Rapid Test Cassette(Saliva)
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette（Saliva ）
SARS-CoV-2 Neutralizing Antibody  Rapid Test Device
 COVID-19 and Influenza A Virus Nucleic Acid Detection Kit (Fluorescent RT-PCR)

359

苏州锐讯生物科技有限公司
Suzhou Precigenome Ltd,Co;

91320594MA1PDDMT5P

CE

SARS-CoV-2 detection kit（RT-PCR）

360

常州爱复康生物科技有限公司
Changzhou IFCAN Biotechnology and Science Co., Ltd.

91320412558024028W

CE

SARS-Cov-2 Antibody Detection Kit

361

苏州长光华医生物医学工程有限公司
Suzhou Hybiome Biomedical Engineering Co., Ltd.

91320505690779858D

CE

SARS-CoV-2 IgG (Chemiluminescent Immunoassay)
SARS-CoV-2 IgM (Chemiluminescent Immunoassay)

362

金紫晶（南京）生物医药技术有限公司
Goldenstar Bio-Pharmaceutical (Nanjing) Co., Ltd.

91320191MA1WYNBKXK

CE

COVID-19 IgM/IgG detection kit (colloidal gold method)

363

济南杏恩生物科技有限公司
Jei Daniel（JD) Biotech Corp.

9137010078060914XX

CE

JDBIOTECH New Coronavirus IgG/IgM Rapid Test Kit (COVID-19 IgG/ IgM)

364

上海药明奥测医疗科技有限公司
WuXi Diagnostics Lab (Shanghai) Co.，Ltd.

91310115MA1K40KF99

CE

SARS-CoV-2 IgG Antibody (ELISA) Detection Kit (Indirect) – REF: AC-nCoV006
SARS-CoV-2 Total Antibodies (ELISA) Detection Kit (Sandwich) – REF: AC-nCoV003

365

杭州奥泰生物技术股份有限公司
Hangzhou Alltest Biotech Co.,Ltd.
(持证公司：Acro Biotech Inc)

91330101685842840Y

CE

2019-nCoV (Novel Coronavirus) IgG/IgM Rapid Test
COVID-19 (Novel Coronavirus) IgG/IgM Rapid Test
COVID-19 Antigen Rapid Test (Cassette) INCP-ACO502
COVID-19 and Influenza A+B Antigen Combo Rapid Test (Cassette) ICIC-ACO525
COVID-19 IgG/IgM Rapid Test (Cassette) (For Reader) INCP-ACOR402
COVID-19 Antigen Rapid Test (Cassette) (For Reader) INCP-ACOR502
COVID-19 IgG/IgM Test Cassette (for Analyzer) ACO-NCP-402
COVID-19 Antigen Test Cassette (for Analyzer) ACO-NCP-502
COVID-19 (Novel Corinavirus) Antigen Rapid Test INCP-ACO802
SARS-COV-2 RT-qPCR Assay ICO-ACOP50

366

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.
（持证公司：Newbury Pharmaceuticals S.A）

91330108589866519M

CE

COVID-19 (SARS-CoV-2) Antibody Test

367

杭州联科生物技术股份有限公司
MultiSciences(Lianke) Biotech,Co.,Ltd.

91330100738418753J

CE

COVID-2019 total Ab ELISA Kit

368

宁波美丽人生医药生物科技发展有限公司
Ningbo Beautiful Life Medical Biotechnology Development Technology Co.,Ltd.

9133020105829155X6

CE

SARS-CoV-2 (2019-nCoV) IgM/IgG Antibody Combined Test kit (Colloidal Gold Assay)
Saliva SARS-Cov-2 (2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay)
Saliva SARS-CoV-2 (2019-nCoV) Antigen Test Kit (Nanocarbon Assay)

369

图凌（杭州）生物医药有限公司
Tuling (Hangzhou) Biomedical Co., Ltd.

91330108MA2B22CG4P

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test (Colloidal Gold)

370

安徽同科生物科技有限公司
Anhui Toneker Biotechnology Co., Ltd.

9134152432278379XA

CE

Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (PCR- fluorescence method)   

371

安徽瀚海博兴生物技术有限公司
Anhui BioX-Vision Biotechnology Co., Ltd

9134010007237452XB

CE

BioX-Vision SARS-CoV-2 Ab/Ag Rapid Test Kit         

372

北京依诺维生物技术有限公司
Innovation Biotech (Beijing) Co., Ltd.

911101140977765412

CE

Coronavirus COVID-19 IgG/IgM Rapid Test Device (Colloidal gold)

373

武汉塞力斯生物技术有限公司
Wuhan Thalys Biotechnology Co., Ltd.

914201127414448134

CE

SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
SARS-CoV-2 (COVID-19) Antigen Fast Detection Kit (Colloidal Gold)

374

苏州海苗生物科技有限公司
Hymonbio Co., Ltd.
(持证公司：dba SpectronRx）

91320585354528566E

U.S. FDA EUA

Hymon SARS-CoV-2 Test Kit

375

无锡科智达科技有限公司
Wuxi Techstar Technology Co.,Ltd.

91320214MA1MXA1A48

CE

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification Fluorescence Method)
SARS-CoV-2 Antigen Test

376

江苏奇天基因生物科技有限公司
Jiangsu Qitian Gene Biotechnology Co., Ltd.

91320213051897030M

CE

SARS-CoV-2 Kit（Fluorescent RT-RAA）

377

南京溯远基因科技有限公司
Nanjing Superyears Gene Technology Co., Ltd

91320111MA1QFH6J4A

CE

SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

378

南京维云生物科技有限公司
Nanjing Weiyun Biotechnology Co., Ltd.

91320191MA1YNW0Q5J

CE

SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
SARS-CoV-2 (COVID-19) Nucleic Acid Detection Kit (Fluorescent RT-PCR)
Nucleic Acid Extraction and Purification Kit

379

苏州苏大赛尔免疫生物技术有限公司
Suzhou Soochow University Saier Immuno Biotech Co.Ltd.

91320594778670005K

CE

2019-nCoV IgG/IgM Device
InstantSure Covid-19 Ag CARD

380

无锡市申瑞生物制品有限公司
Wuxi Shenrui Bio-pharmaceuticals Co., Ltd

91320206714928150N

CE

Covflu-SR,Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection kit

381

济南德亨医学科技有限公司
Jinan Deheng Medical Technology Co.,Ltd

91370105054853850Q

CE

The Diagnostic Kit for IgM / IgG Antibody to SARS-CoV-2 (Colloidal Gold)

382

青岛厚美德生物科技有限公司
YASEE Biomedical Inc.

913702225878348042

CE

2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold Method)

383

威海康州生物工程有限公司
Weihai Kangzhou Biotechnology Engineering Co., Ltd.

913710000659164741

CE

COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
COVID-19 Antigen Rapid Test
SARS-COV-2 Neutralizing Antibody Rapid Test
2019-nCOV Direct qPCR Kit

384

上海贝德尔生物科技有限公司
Shanghai Biodell Biotechnology Co., Ltd.
（持证公司：Shanghai Bionaire Biotech. Co., Ltd.）

913101203506881750

CE

Novel Coronavirus (COVID-19) Antibody (IgM/IgG) Test

385

浙江夸烨生物科技有限公司
Zhejiang Kuaye Biotechnology Co., Ltd.

91330604MA2BELDQX2

CE

Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)
Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Novel Coronavirus (SARS-CoV-2) & Influenza Antigen Combo Rapid Test Kit (Colloidal Gold Immunochromatography)

386

杭州浙大迪迅生物基因工程有限公司
Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.
(持证公司：Zentech S.A.)

91330108757206959N

CE

QuickZen COVID-19 lgM/IgG (S-LW-25)

387

浙江自贸区锐赛生物医药科技有限公司
Zhejiang Free Trade Zone R&S Biomedical Technology Co.,Ltd.

91330903MA2A2FEL2D

CE

Coronavirus (SARS-COV-2) Specific antibody IgG/IgM Test Kit (Colloidal Gold)
Coronavirus (SARS-COV-2) Nucleic Acid test Kit (PCR Fluorescence)

388

安徽鼎晶生物科技有限公司
Anhui Topgen Biological Technology Co., Ltd.

91341222MA2N0L594M

CE

SARS-CoV-2 Real-time Reverse Transcriptase （RT）-PCR Detection Kit 

389

北京阿匹斯生物科技有限公司
Beijing Apis Bioscience Co., Ltd

91110302MA01PYJE26

CE

SARS-CoV-2 nucleic acid detection kit (Fluorescent PCR)
SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method

390

广州赛哲生物科技股份有限公司
Guangzhou Sagene Biotech Co.,Ltd.

914401015583683498

CE

Novel coronavirus (SARS-CoV-2) NGS Test Kit (Sequencing by Synthesis)
Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (fluorescent PCR method）

391

广东盛泽康华生物医药有限公司
Seinda Biomedical Corporation

914401013313355858

CE

SARS-CoV-2 Antigen Test (CoVisAg)

392

珠海经济特区海泰生物制药有限公司
Zhuhai Haitai Biological Pharmaceutical Co., Ltd

91440400617507469D

CE

Novel Coronavirus (SARS-CoV-2) ORF1ab/N gene Detection Kit (Real-time fluorescent PCR)

393

中山大学达安基因股份有限公司
Da An Gene Co.,Ltd. of Sun Yat-sen University

91440101190445368X

CE

Detection Kit for 2019 Novel Coronavirus (2019-nCoV)RNA (PCR-Fluorescence Probing)
Detection Kit for 2019-nCoV (PCR-Fluorescence)

394

中山生物工程有限公司
Zhongshan Bio-tech Co.,Ltd.

91442000282020682B

CE

SARS-CoV-2 IgM-IgG (GICA)
COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)

395

湖南远璟生物技术有限公司
Hunan Yuanjing Biotechnology Co.,Ltd

91430105MA4L26123K

CE

COVID-19 Total Antibody Rapid Test Kit (Colloidal Gold)

396

哈尔滨星云医学检验所有限公司
Harbin Nabula Medical Laboratory Co.Ltd.

91230199MA18WFMM13

CE

SARS-CoV-2 RT-PCR Kit

397

北京美联泰科生物技术有限公司
Sophonix Co.,Ltd.

91110302MA00G8EH41

CE

SARS-CoV-2 IgG antibody test kit
SARS-CoV-2 IgM antibody test kit
Severe Acute Respiratory Coronavirus 2 S1 Protein test kit (Magnetic particle chemiluminescence method)
SARS-CoV-2 N Protein CLIA test kit
SARS-CoV-2 IgG CLIA test kit
SARS-CoV-2 Neutralization Antibody CLIA Detection Kit

398

湖北美宝生物科技股份有限公司
Hubei MEIBAO Biotechnology Co., Ltd.

914208006917946620

CE

Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19
2019-nCoV Antigen Rapid Test Kit (Colloidal Gold)

399

湖南溢康源明医疗器械有限公司
Hunan Yikang Yuanming Medical Equipment Co., Ltd.

91430100MA4R4Q28X6

CE

SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

400

碧迪快速诊断产品（苏州）有限公司
BD Rapid Diagnostics (Suzhou) Co., Ltd.
（持证公司：Becton,Dickinson and Company (BD)）

91320594788380757Q

U.S. FDA EUA

BD Veritor System for Rapid Detection of SARS-CoV-2

401

探原子医学科技（苏州）有限公司
Genosor Medical Science&Technology Inc.

91320505MA2136A088

CE

SARS-CoV-2 Isothermal Amplification Detection Kit

402

银丰基因科技有限公司
Yinfeng Gene Technology Co.,Ltd.

91370100353481495P

CE

Detection Kit for 2019-nCoV (PCR-Fluorescence Probing)

403

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.

91330108589866519M

U.S. FDA EUA

LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

404

北京吉检医疗科技有限公司
Beijing GeneDetective Medical Technology Co., Ltd.

91110114MA01LPGB20

CE

Detection kit for novel coronavirus (SARS CoV-2) RNA (Multiplex Fluorecent RT-PCR)

405

无锡市孚维尔生物医疗科技有限公司
Wuxi Fuweier Bio-medical Technology Co,Ltd

91320206MA1XH4J2XP

CE

SARS-CoV-2 IgM/IgG Antibody Quick Test Kit (Colloidal Gold)

406

三明博峰生物科技有限公司
Sanming Bofeng Biotechnology Co.,Ltd

91350400735666073F

CE

Novel Coronavirus (SARS-CoV-2) Antibody IgM/IgG Kit (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) Antibody Kit (Colloidal Gold)

407

广东优尼德生物科技有限公司
Guangdong Uniten Biotechnology Co.,Ltd.

914419003980902607

CE

SARS-CoV-2 IgM/IgG Detection kit (Colloidal Gold-based)
SARS-CoV-2 S1 IgG ELISA kit

408

广州春康生物科技有限公司
Guangzhou Chunkang Biotechnology Co.,Ltd.

91440115347511002K

CE

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Rapid Test Kit（Immunochromatography）

409

珠海迈科智能科技股份有限公司
Zhuhai Gotech Intelligent Technology Co.,Ltd.

91440400675231413R

CE

2019-nCoV IgG/IgM Rapid Test       

410

桂林中辉科技发展有限公司
Guilin Zhonghui Technology Co., Ltd

91450322199097320F

CE

COVID-19 IgM TEST(Colloidal Gold Immuno-chromatography)
COVID-19 IgG TEST(Colloidal Gold Immuno-chromatography)

411

湖南宏雅基因技术有限公司
Hunan Hoomya Gene Technology Co.,Ltd.

914301000682420063

CE

SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)

412

长春西诺生物科技有限公司
Changchun Sino Biotechnology Co., Ltd.

912201017765690186

CE

2019-nCoV ANTIBODY RAPID TEST KIT (Colloidal Gold Method)

413

深圳澳东检验检测科技有限公司
Shenzhen Aodong Inspection & Testing Technology Co., Ltd.

91440300766394306D

CE

Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method)

414

罗氏诊断产品（苏州）有限公司
Roche Diagnostics (Suzhou) Ltd.
（持证公司：Roche Diagnostics ）

913205943295977626

U.S. FDA EUA

Elecsys Anti-SARS-CoV-2

415

罗氏诊断产品（苏州）有限公司
Roche Diagnostics (Suzhou) Ltd.
（持证公司：Roche Diagnostics  GmbH）

913205943295977626

CE

Elecsys Anti-SARS-CoV-2

416

温州欧斯达康生物科技有限公司
Wenzhou Astock Biotechnology Co., Ltd.

9133030478770000XL

CE

COVID-19 IgG/lgM Rapid Test Cassette (Colloidal gold)
New Coronavirus COVID‐19 Nucleic Acid Detection Kit (Fluorescence RT‐PCR Method)
COVID-19 Antigen Rapid  Test Cassette (Colloidal Gold)

417

亳州市新健康科技有限公司
Bozhou Xinjiankang Science and Technology Co., Ltd

91341600MA2MRFA7X1

CE

COVID-19 Rapid Test Cassette

418

桂林世康医疗科技有限公司
Guilin Shikang Medical Technology Co., Ltd

91450300MA5KENJW6N

CE

Diagnostic kit for Detection of IgG/IgM Antibody to SARS-CoV-2(Colloidal Gold)

419

杭州安旭生物科技股份有限公司
Assure Tech (Hangzhou) Co.,Ltd.

913301066767726252

U.S. FDA EUA

Assure COVID-19 IgG/IgM Rapid Test Device

420

江西诺禾致源医学检验有限公司
Jiangxi nuohe Zhiyuan Medical Examination Co. , Ltd.

91360121MA390KDF0J

CE

COVID-19 (SARS-CoV-2) IgG/IgM Delection Kit (Colloidal Gold-Based)

421

江西赛基生物技术有限公司
Jiangxi Cellgene Biotech Co., Ltd.

91360106MA35XBX90W

CE

COVID­19 IgM/IgG Rapid Test Kit
SARS­CoV­2 Real­Time RT­PCR Assay

422

广州市雷德生物科技有限公司
Guangzhou Leide Biosciences Co., Ltd.

91440101082721417M

CE

SARS-CoV-2 IgG Antibody Diagnostic Kit (ELISA)
SARS-CoV-2 IgM Antibody Diagnostic Kit (ELISA)
SARS-CoV-2 Neutralization Antibodies ELISA Kit
SARS-CoV-2 T Cell Assay

423

深圳市博卡生物技术有限公司
Shenzhen Biocup Biotech Co.,Ltd.

91440300723003539M

CE

SARS-CoV-2 IgM/IgG Antibody Test Kit(Colloidal Gold)
SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)

424

北京万泰生物药业股份有限公司
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

91110114600067778R

U.S. FDA EUA

WANTAI SARS-CoV-2 Ab Rapid Test
WANTAI SARS-CoV-2 Ab ELISA
Wantai SARS-CoV-2 RT-PCR Kit

425

山东艾克韦生物技术有限公司
Shandong ACV Biotech Co.,ltd..

91370100798859788J

CE

SARS-CoV-19(ORF1ab) / N Gene;Nucleic Acid Detection Kit Fluorescence Qualitative RT-PCR

426

宁波紫园医疗器械有限公司
Ningbo Ziyuan Medical Device Co.,Ltd.

91330226MA2819F2X2

CE

Accufast-8 SARS-CoV-2 Antibody Test Kit (Rapid Chemiluminescent immunoassay)
Accufast-8 SARS-CoV-2 IgM Test Kit (Rapid Chemiluminescent immunoassay)
Accufast-8 SARS-CoV-2 IgG Test Kit (Rapid Chemiluminescent immunoassay)

427

北京中生金域诊断技术股份有限公司
Beijing Zhongsheng Jinyu Diagnostic Corporation Co.,Ltd.

91110114746701241M

CE

COVID-19 IgM/IgG Antibody Test Kit (Immunochromatography Assay)

428

杭州祥音生物医药科技有限公司
Hangzhou Xiangyin Biological Medicine Technology Co., Ltd.
（持证公司：Wenzhou OJA Biotechnology Co.,Ltd.)

91330106599594529W

CE

Real-time PCR Kit for Rapid Detection of SARS-CoV-2

429

北京望尔生物技术有限公司
Beijing Wanger Biotechnology Co.,Ltd.

91110108742303713T

CE

COVID-19 IgG/IgM Rapid Test Kit

430

北京全式金生物技术有限公司
TransGen Biotech Co., Ltd

911101087868832114

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR)
Trans SARS-CoV-2 & Influenze A/B Assay

431

石家庄卢米特生物科技有限公司
Shijiazhuang Lumitest Biotechnology Co., Ltd.

91130101MA09N5BA6E

CE

COVID-19 IgG/IgM Rapid Test Kit

432

北京华大吉比爱生物技术有限公司
Beijing BGI-GBI Biotech Co., Ltd.

91110108600023388J

CE

SARS-CoV-2 Total Antibody Detection Kit (Fluorescence Immunochromatographic)
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Fluorescence Immunochromatographic)
SARS-CoV-2 (2019-nCoV) detection kit (PCR-probing)
SARS-CoV-2 Neutralizing Antibody Detection Kit (ELISA)

433

深圳华因康基因科技有限公司
Shenzhen HYK Gene Technology Co.,Ltd.

914403006718503053

CE

SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT PCR)
COVID 19 (SARS CoV 2) IgM/IgG Antibody Test Kit (Colloidal Gold)

434

广纳信捷（广州)医疗科技有限公司
Guangzhou CanGeno Co.,Ltd.

91440101MA5D429C03

CE

Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit

435

江苏康为世纪生物科技股份有限公司
Jiangsu CoWin Biotech Co., Ltd

91321291561773986P

U.S. FDA EUA

Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

436

深圳德夏生物医学工程有限公司
Diasia Biomedical Technology Co.,Ltd.

914403000679541245

CE

SARS-CoV-2 IgG/IgM GICA Rapid Test
Diagnostic Kit for SARS-CoV-2 Nucleic Acid(RT-PCR)
Diagnostic Kit for SARS-CoV-2 Ag
SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (Colloidal Gold)

437

河北博海生物工程开发有限公司
Hebei Bio-High Technology  Development Co.,Ltd

91130100601901066D

CE

New Coronavirus (SARS­CoV­2) IgM/IgG antibodies test

438

天津微纳芯科技有限公司
Tianjin MNCHIP Technologies Co., Ltd.

9112011655948734F

CE

Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay)

439

北京博晖创新生物技术股份有限公司
Beijing Bohui Innovation Biotechnology Co., Ltd.

91110000726362190T

CE

Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip)
COVID-19 IgM/IgG Antibodies Rapid Test (Colloidal Gold Method)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay)
Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit

440

深圳海思安生物技术有限公司
Shenzhen Haisian Biotech Co.,Ltd.

91440300MA5DP0MD0Q

CE

COVID-19 IgM/IgG Combo Rapid Test

441

北京九强生物技术股份有限公司
Beijing Strong Biotechnologies,Inc.

911100008020705889

CE

SARS CoV-2 Antibody Test Kit (Latex Immunoturbidimetric Method)
SARS CoV-2 Antigen Test Kit

442

厦门宝太生物科技有限公司
Xiamen Biotime Biotechnology Co., Ltd.

91350205671268681J

U.S. FDA EUA

BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

443

厦门中生朗捷生物技术有限公司
Xiamen Zhongsheng Langjie Biotechnology Co.,Ltd

91350205089918239A

CE

SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)
COVID-19 Antigen Test Cassette (hypersensitive colloidal gold)

444

广州海力特生物科技有限公司
Guangzhou SupBio Bio-Technology and Science Co.,Ltd.

91440116554412824J

CE

SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (PCR-Fluorescent Probing)

445

武汉博杰生物医学科技有限公司
Wuhan Bojie Biomedical Technology Co.,Ltd.

91420100MA4KLXQB2Y

CE

Novel coronavirus 2019 (2019-nCoV) CRISPR rapid nucleic acid detection kit

446

圣湘生物科技股份有限公司
Sansure Biotech Inc.

91430100673566826X

U.S. FDA EUA

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

447

浙江派迪畅科技发展有限公司
AnyGo Technology（Zhejiang） Co., Ltd.
（持证公司：AnyGo Technology Co., Ltd）

91330800MA2DG1GB44

CE

SARS-CoV­2 Protective Antibody Assay Kit (ELISA)

448

中国科学院大学宁波生命与健康产业研究院
Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences

12330200MB1653994K

CE

SARS-CoV-2 ANTIBODY TEST KIT (Chemiluminescent immunoassay)
SARS-CoV-2 IgG TEST KIT (Chemiluminescent immunoassay)
SARS-CoV-2 IgM TEST KIT (Chemiluminescent immunoassay)

449

固安林科特生物工程有限公司
Atlas Link Technology Co., Ltd

911310225619870608

CE

NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold)
NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

450

广州德成生物科技有限公司
Guangzhou Decheng Biotechnology Co.,Ltd.

91440101MA5CKKAA6M

CE

SARS-CoV-2 Antibody Rapid Test Kit
SARS-CoV-2 IgG&IgM Antibody Rapid Test Kit
SARS-CoV-2 Ag Rapid Test Kit
(Fluorescence Immunochromatographic)
SARS-CoV-2 IgG&IgM Antibody Rapid Test Kit
(Colloidal Gold)
SARS-CoV-2 Ag Rapid Test Kit(Immunochromatography)
2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)
2019-nCoV Ag Saliva Rapid Test Cup (Immunochromatography)
2019-nCoV Ag Saliva Rapid Test Kit (Immunochromatography)
2019-nCoV Ag Rapid Test Kit (Immunochromatography)
2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)
2019-nCoV IgG&IgM Antibody Rapid Test Kit (Immunochromatography)
2019-nCoV IgG&IgM Antibody Rapid Test Kit (Colloidal Gold)
2019-nCoV Antibody Rapid Test Kit (Immunochromatography)
2019-nCoV Neutralizing Antibody Rapid Test (Immunochromatography)
2019-nCoV Neutralizing Antibody Rapid Test (Fluorescence Immunochromatographic Assay)
2019-nCoV Ag & FLU A/B COMBO Rapid Test(Immunochromatography)
2019-nCoV Ag Saliva Rapid Test Kit(Fluorescence Immunochromatographic Assay)
2019-nCoV Ag Quantitative Test Kit(Fluorescence Immunochromatographic Assay)
2019-nCoV RBD Antibody Rapid Test (Immunochromatography)
2019-nCoV RBD Antibody Rapid Test (Fluorescence Immunochromatographic Assay)

451

广州瑞辉生物科技股份有限公司
Guangzhou Rhfay Biological Medical Technology Corp. Ltd

914401010506416155

CE

COVID-19 IgM/IgG Antibody Rapid Test Kit (colloidal gold Assay)

452

上海贝德尔生物科技有限公司
Biodell Biotechnology Co., Ltd
（持证公司：Shanghai Chuangkun Biotech Inc.）

913101203506881750

CE

Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (Lyophilized)

453

厦门海菲生物技术有限公司
Xiamen Haifei Biotech Co., Ltd.

91350211769261437J

CE

Rapid 2019-nCoV IgG/IgM Combo Test Card (Colloidal gold)

454

上海凯创生物技术有限公司
Shanghai Chemtron Biotech.Co.,Ltd.
（持证公司:Cypress Diagnostics）

913101156074267293

CE

COVID-19 IgM/IgG Rapid Test

455

杭州百迈生物股份有限公司
Hangzhou KBM Life Sciences Co., Ltd.

913301000536794910

CE

Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (RT-PCR)

456

北京鑫诺美迪基因检测技术有限公司
Beijing SinoMDgene Technology Co.,Ltd

91110302682851418Y

CE

Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit

457

清源之光（武汉）生物科技有限公司
Tsinglight (Wuhan) Biotechnology Co., Ltd

91420100MA49HFUB79

CE

SARS-CoV-2 (COVID-19) Antibody Rapid Detection Kit
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit

458

厦门致善生物科技股份有限公司
Xiamen Zeesan Biotech Co., Ltd.

91350200556210281J

U.S. FDA EUA

SARS-CoV-2 Test Kit (Real-time PCR)

459

珠海赛乐奇生物技术股份有限公司
Zhuhai Sinochips Bioscience Co.,Ltd.

91440400779214933J

U.S. FDA EUA

COVID-19 Nucleic Real-time PCR Test Kit

460

深圳市惠安生物科技有限公司
Shenzhen Huian Biosci Technology  Co.,Ltd.

91440300760474065D

CE

SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)
Rapid nCoV & Flu A/B Ag Test Kit  (Colloidal Gold)
SARS-CoV-2 Antigen Test Kit  (Colloidal Gold)

461

禾旭（郑州）生物技术有限公司
Helix Inc.

91410100MA9F5307XN

CE

e-SARS-CoV-2 Total Ab ELISA Kit
Helix i-SARS-CoV-2 IgG/IgM Ab Rapid Test
Helix i-SARS-CoV-2 Ag Rapid Test

462

津泰（天津）医疗器械有限公司
Jinston (Tianjin) Medical Devices Co., Ltd.

91120118MA06YX6E0P

CE

2019-nCoV Detection Kit (isothermal amplification-fluorescent probe method)

463

四川质谱生物科技有限公司
Sichuan Mass Spectrometry Biotechnology Co., Ltd

91510123MA6ADXN125

CE

Novel Coronavirus (2019-nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
Fluorescent PCR Probe Detection Kit for SARS-CoV-2

464

江苏为真生物医药技术股份有限公司
Jiangsu Microdiag Biomedicine Technology Co., Ltd.

91320594679847274E

CE

Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (LFD method)
Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (qRT-PCR method)

465

无锡百泰克生物技术有限公司
BioTeke Corporation （Wuxi） Co.,Ltd

913202065617502076

CE

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit(Fluorescence PCR)
SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method)
SARS-CoV-2 Antigen Test Kit (colloidal gold method)
SARS-CoV-2  IgM/IgG Antibody Test Kit (colloidal gold method)
SARS-CoV-2 Antigen Test Kit (colloidal gold method)

466

碧迪快速诊断产品（苏州）有限公司
BD Rapid Diagnostics(Suzhou) Co., Ltd.
（持证公司：Becton, Dickinson and Company (BD)）

91320594788380757Q

CE

BD Veritor System for Rapid Detection of SARS-CoV-2
BD Kit for Rapid Detection of SARS-CoV2

467

杭州昱鼎生物科技有限公司
Hangzhou York Biotech Co., Ltd.

91330109MA2AXRQY7N

CE

SARS-COV-2 Antigen Rapid Test Kit
SARS-CoV-2 IgM/IgG Rapid Test Kit
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent RT- PCR)

468

清源生物(深圳)有限公司
Qingyuan Biotech (Shenzhen) Co.,Ltd.

91440300MA5FFC2QX0

CE

SARS-CoV-2 (COVID-19) Antibody Rapid Detection Kit

469

杭州德同生物技术有限公司
Hangzhou Dalton BioSciences, Ltd.
（持证公司：Inno-Bio(shanghai) biomedical Co.,ltd.）

913301086970931707

CE

SARS-CoV-2 Antigen Rapid Test

470

泽达精准（杭州）生物医药有限公司
Zeda Precision (Hangzhou) Biopharmaceutical Co., Ltd.

91330108MA2H00DC74

CE

Novel Coronavirus S1 Protein Antigen Detection Kit (Latex)
Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Detection Kit (Colloidal Gold)
Novel Coronavirus /Influenza Virus A/B Antigens Multiple Detection Kit (Latex)
Serum Neutralizing Antibody Rapid Detection Kit For COVID-19 (Quantum dot Fluorescence)

471

浙江派迪畅科技发展有限公司
AnyGo Technology（Zhejiang） Co., Ltd.

91330800MA2DG1GB44

CE

Rapid Immunochromatographic Assay (RICA) for SARS-CoV-2 antibodies

472

安徽微分基因科技有限公司
Anhui Microanaly Genetech Co.Ltd

91340100MA2NQTD2J

CE

Diagnostic Kit for Corona Virus Disease 2019 (COVID-19) RNA (Isothermal Amplification- Lateral Flow Dipstick Assay)
Diagnostic Kit for Corona Virus Disease 2019 (COVID-19) RNA (Loop-mediated Isothermal Amplification)

473

南京美宁康诚生物科技有限公司
Mei Ning Kang Cheng China Biotechnology R&D Center, Inc.

913201000532863051

CE

SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
Coronavirus Disease 2019 (Covid-19) IgM/IgG Rapid test (Colloidal Gold Assay)

474

宁波人健瑞信生物科技有限公司
Ningbo Renjian Ruixin Biotechnology Co., Ltd.

91330282MA2H6EM4XB

CE

Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR)

475

南京金斯瑞生物科技有限公司
Nanjing GenScript Biotech Co., Ltd.

913201156825376724

CE

SARS-CoV-2 RT-qPCR detection kit, 1-plex (N)
SARS-CoV-2 RT-qPCR detection kit,1-plex (ORFlab)
SARS-CoV-2 RT-qPCR detection kit,2-plex (ORFlab&N)
SARS-CoV-2 Spike S1-RBD IgG&IgM ELISA Detection Kit
SARS-CoV-2 IgG&IgM Rapid Detection Kit (Colloidal Gold)
SARS-CoV-2 Surrogate Virus Neutralization Test Kit
cPassTM SARS-CoV-2 Neutralization Antibody Detection Kit

476

青岛巴特菲科技发展有限公司
Qingdao Biotephy Co.,Ltd.

91370222MA3T2MYB63

CE

SARS-CoV-2 Real-time RT-PCR Detection Kit (Lyophilized or Liquid)
SARS-CoV-2 , Influenza A virus, Influenza B virus Triplex Real-time RT-PCR Detection Kit (Lyophilized or Liquid)

477

深圳市辰纳生物科技有限公司
ShenZhen Channel Biotechnology Co., Ltd.

91440300MA5DPQJ57J

CE

SARS-CoV-2 IgG Ab Determination Kit( Chemiluminescence Immunoassay )
SARS-CoV-2 IgM Ab Determination Kit( Chemiluminescence Immunoassay )
SARS-CoV-2 Ag Determination Kit( Chemiluminescence Immunoassay)

478

杭州众测生物科技有限公司
Hangzhou Zhongce Biotechnology Co.,Ltd.

91330108MA27YKNR43

CE

2019-nCoV Nucleic Acid Fluorescent Isothermal Amplification Detection Kit (RT-RAA)
The Detection Kit for 2019 Noval Coronavirus (2019-nCoV) RNA (CRISPR-LFA)

479

诺迦（杭州）生物工程有限公司
New Gene (Hangzhou) Bioengineering Co., Ltd.
（持证公司：Assut Europe Spa）

91330108MA2H3RX57K

CE

SPIKE GLYCOPROTEIN DETECTION KIT
(COVID-19/AG)

480

杭州睿丽科技有限公司
Hangzhou Realy Tech Co., Ltd.

913301013219351652

CE

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)
SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab)
2019-nCOV IgG/IgM Rapid Test Device(Whole blood/Serum/Plasma)
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)

481

济南百博生物技术股份有限公司
Jinan Babio Biotechnology Co.,Ltd.

913701007563575874

CE

SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)
SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)
SARS-CoV-2 Antigen Detection Kit (Latex immunochromatography)

482

江苏宏微特斯医药科技有限公司
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

91320623MA1MKF9Q90

CE

SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence Chromatography)
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel
Coronavirus(SARS-CoV-2)
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)
Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens

483

江西乐成生物医疗有限公司
Jiangxi Lecheng Biomedical Co., Ltd

91361100MA35JPYC36

CE

SARS-CoV-2 IgG/IgM antibody detection kit (Urine sample, colloidal gold method)
SARS-CoV-2 IgG/IgM antibody detection kit (Blood sample, colloidal gold method)

484

北京华科泰生物技术股份有限公司
Beijing Savant Biotechnology Co., Ltd.
（持证公司：LOMINA SUPERBIO a.s.）

9111010679755822XC

CE

SARS-CoV-2 N-Protein Antigen Rapid Test

485

深圳市达科为生物工程有限公司
Shenzhen Dakewe Bio-engineering Co.,Ltd.

914403005879322954

CE

Saliva SARS-CoV-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay)
2019-nCoV Real Time PCR Kit
COVID-19 Antigen Rapid Test Kit

486

苏州和锐生物科技有限公司
Suzhou Herui BioMed Co., Ltd

91320594596935615L

CE

SARS-CoV-2 immunoglobulin G (IgG)/IgM Antibody Detection  Kit （immunochromatographic test (ICT) rapid）

487

上海妙灵生物工程有限公司
Amazing Biotech （Shanghai） Co.,Ltd.

91310115MA1HB46DX9

CE

COVID-19 Antigen Sealing tube test strip (Colloidal Gold)
COVID-19 Ab (IgG/IgM) Sealing Tube Test Strip (Colloidal Gold)
COVID-19 Ag/Ab (IgG/IgM) Sealing Tube Twin Test Strip (Colloidal Gold)  
COVID-19 Ag/Ab (IgG/IgM) and Influenza Ag (A/B) Sealing Tube Twin Test Strip (Colloidal Gold)  

488

美林美邦（厦门）生物科技有限公司
Merlin Biomedical (Xiamen) Co., Ltd.

91350200MA2XYNBD5K

CE

Novel Coronavirus (COVID-19) RT-PCR Kit

489

无锡博慧斯生物医药科技有限公司
Wuxi Biohermes Bio & Medical Technology Co., Ltd.

91320211793310403C

CE

SARS-CoV-2 Neutralizing Antibodies Test Kit (enzyme linked immunosorbent assay)
SARS-CoV-2 IgG Antibody Test (Lateral Flow Assay)
SARS-CoV-2 IgG/IgM Antibody Test (Lateral Flow Assay)
SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay）

490

深圳华大因源医药科技有限公司
BGI PathoGenesis Pharmaceutical Technology Co.,Ltd.

91440300MA5FRN4T2F

CE

Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2, Influenza A Virus and Influenza B Virus
Multiplex Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2, Influenza A Virus and Influenza B Virus

491

深圳市帝迈生物技术有限公司
Shenzhen Dymind Biotechnology Co., Ltd.

91440300071753771K

CE

SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)
SARS-CoV-2 Antigen Test Kit(Colloidal Gold)

492

杭州方沃生物科技有限公司
Hangzhou Funworld Biotech Co., Ltd.

91330110MA2H3UYJ6X

CE

SARS-CoV-2 Ag Rapid Test Device (Nasopharyngeal swabs/ Nasal swab)
SARS-CoV-2 IgG/IgM Rapid Test Device (WB/P/S)
Influenza A+B/ SARS-CoV-2 Ag Rapid Test Device (Nasopharyngeal swabs/ Nasal swab)
SARS-CoV-2 Neutralizing Antibody Rapid Test Device

493

江苏达伯药业有限公司
Jiangsu Dablood Pharmaceutical Co., Ltd

91320118MA1NBWNF6Q

CE

SARS-Cov-2 Antigen Test
INFLUENZA A, INFLUENZA B and NOVEL CORONAVIRUS (SARS-CoV-2) NUCLEIC ACID DIAGNOSTIC KIT (PCR-FLUORESCENCE PROBING)

494

南京金斯瑞生物科技有限公司
Nanjing GenScript Biotech Co., Ltd.
（持证公司：GenScript USA Inc.）

913201156825376724

U.S. FDA EUA

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

495

南京海珀生物科技有限公司
Health Port Biotech Co.,Ltd

91320113MA1X0UDH2Q

CE

COVID-19 IgM/IgG Antibody Combo Test Kit

496

北京望升伟业科技发展有限公司
Beijing WSWY Science Technology Co., Ltd.

911101087754750524

CE

Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-based Fluorescence Immunochromatography)

497

宁波弘肽生物技术有限公司
Ningbo Home Test Bio-technology Co.,Ltd.

91330205MA2GW9GP0U

CE

SARS-CoV-2 IgG/IgM Rapid Test Kit
SARS-CoV-2 Antigen Rapid Test Kit
SARS-CoV-2 IgG/IgM/IgA Antibody Rapid Test(Colloidal Gold)
SARS-CoV-2 +FluA&B Antigen Combo Rapid Test(Colloidal Gold)
SARS-COV-2 Nucleocapsid protein Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold)
SARS-COV-2 Total Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold)
SARS-CoV-2 Antigen Rapid Test(Colloidal Gold)
SARS-COV-2 Neutralizing Antibdoy Rapid Test (Colloidal Gold)SARS-CoV-2 Antigen Rapid Test (Saliva test)

498

杭州微策生物技术股份有限公司
VivaChek Biotech (Hangzhou) Co., Ltd.
（持证公司：Nal Von Minden GmbH.）

913301000743141922

CE

Covid-19 Ag+Influenza A/B Test
COVID-19 Ag Test

499

浙江迪恩生物科技股份有限公司
Zhejiang Dien Sci-tech Corp.,Ltd.

9133010075172312X2

CE

2019-nCoV antigen rapid detection strip (colloidal gold)

500

北京易斯威特生物科技股份有限公司
Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.

91110115755270009B

CE

Antigen-COVID-19 Virus Test Kit (Colloidal gold)

501

山东康华生物医疗科技股份有限公司
Shandong Kanghua Biotechnology Co.,Ltd.

91370700266827355D

CE

SARS-CoV-2 Antigen Rapid Test

502

杭州恒奥科技有限公司
Hangzhou HEO Technology Co., Ltd.

91330106586530788B

CE

COVID-19 IgG/IgM Rapid Test Cassette (Colloidal gold)
COVID-19 Antigen Rapid  Test Cassette (Colloidal Gold)
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette

503

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.
（持证公司：GenaBio Diagnostics Inc）

91330108589866519M

CE

GenaBio SARS-CoV-2 Antigen Lateral Flow Test

504

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.
（持证公司：Genabio LLC）

91330108589866519M

CE

SARS­CoV­2 IgM/IgG (GICA)

505

杭州协合医疗用品有限公司
Hangzhou Singclean Medical Products Co.,Ltd.
（持证公司：Multibrands Trading(Suzhou) Co., Ltd.)

91330101747181911R

CE

SARS-CoV-2 Antigen Rapid Qualitative Test
SARS-CoV-2/FluA/FluB Antigen Combo Rapid Test Kit

506

深圳逗点生物技术有限公司
Biocomma Limited

91440300791729139X

CE

Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)
COVID-19 Antigen Test Kit（Lateral Chromatography）

507

河北精硕生物科技有限公司
Hebei Gensure Biotech Inc.
（持证公司：Aesku.Diagnostics GmbH & Co.KG）

91130182MA082NNG5P

CE

AESKU.RAPID SARS-CoV-2

508

湖南超亟检测技术有限责任公司
Hunan Targeting Detection Technology Co., Ltd.

91430100MA4PMB1DX6

CE

Rapid Visual Novel Coronavirus 2019-nCoV Nucleic Acid Test Kit

509

江苏苏博生物医学科技南京有限公司
Jiangsu Superbio Biomedical (Nanjing) Co.,Ltd.
（持证公司：Nanjing Weiyun Biotechnology Co., Ltd.）

91320191MA1MFFL48D

CE

SARS-CoV-2 Antigen Rapid Test Kit (Latex immunochromatography)

510

浙江艾明德生物科技有限公司
Zhejiang Aiminde Biotechnology Co.,Ltd.

91330523MA28CYM574

CE

Novel Coronavirus Ag Rapid Test Cassette

511

浙江数问生物技术有限公司
Zhejiang Shuwen Biotech Co., Ltd.

91330500562366936R

CE

SARS-CoV-2 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

512

杭州安旭生物科技股份有限公司
Assure Tech. (Hangzhou) Co., Ltd.
(持证公司：BTNX, Inc.)

913301066767726252

CE

Rapid Response™ COVID-19 Antigen Rapid Test Device

513

河北康立德生物科技有限公司
Hebei Collead Biotech Co., Ltd.

91130101MA0ELN0C57

CE

SARS-CoV-2 Antigen Test (Colloidal Gold)

514

上海捷诺圣华生物科技有限公司
Shanghai GeneSc Biotech Company Limited

91310104MA1FRL7K5P

CE

Novel Coronavirus 2019-nCov Rapid Detection Kit (LAMP)

515

广东南芯医疗科技有限公司
Guangdong Longsee Biomedical Co.,Ltd.

91440101MA59A05J6T

CE

2019-nCoV Ag & Influenza A/B Ag Rapid Co-Detection Kit (Immuno-Chromatography)
2019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method)
2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) LS-C-T-008
2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) LS-C-T-009
2019-nCoV Neutralizing Antibody Test Kit (Immuno-Chromatography)

516

广州奕昕生物科技有限公司
Yixin Bio-Tech (Guangzhou) Co., Ltd.

914401163047183020

CE

COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold Immunochromatography)

517

佛山市顺德区德维医疗科技有限公司
Dewei Medical Equipment Co.,Ltd.

91440606MA5534NA6H

CE

COVID-19 (2019-nCoV) Nucleic Acid Detection kit (PCR-Fluorescence Probing)
COVID-19 (2019-nCoV) IgG/IgM Rapid Test Cassette   
Covid-19 (2019-nCoV) Antigen Rapid Test Cassette 

518

赛莱克斯生物科技（苏州）有限公司
Cellex Biotech (Suzhou) Co., Ltd

91320505321623444A

CE

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test(Lateral Flow Chromatographic Immunoassay)
Cellex qSARS-CoV-2 Antigen Rapid Test(Lateral Flow Chromatographic Immunoassay)
Helix i-SARS-CoV-2 Ag Rapid Test(Lateral Flow Chromatographic Immunoassay)
Helix i-FIu/COVID-19 Ag Combo Rapid Test (Lateral Flow Chromatographic Immunoassay)
Helix e-SARS-CoV-2 Total Ab ELISA Kit (ELISA)

519

深圳麦科田生物医疗技术股份有限公司
Medcaptain Medical Technology Co.,Ltd.

91440300573106363N

CE

SARS-CoV-2 Antigen (GICA)
SARS-CoV-2 NAbs（CLIA）
SARS-CoV-2 IgG/IgM（GICA）
SARS-CoV2-IgG (CLIA)
SARS-CoV2-IgM (CLIA)
FluA/FluB/SARS-CoV-2 Antigen（GICA）

520

江苏维尔生物科技有限公司
Jiangsu Well Biotech Co., Ltd.

91320413796137618Y

U.S. FDA EUA

COVID-19 IgM/IgG Rapid Test (Colloidal Gold)

521

杭州协合医疗用品有限公司
Hangzhou Singclean Medical Products Co.,Ltd.
（持证公司：Multibrands International Ltd.)

91330101747181911R

CE

Panodyne COVID-19 (SARS-CoV-2) Test Cassette Kit & Strip type IgM-IgG Rapid Point of care Diagnosis Test of Coronavirus Infection

522

中秀科技股份有限公司
Zhongxiu Science And Technology Co.,Ltd.

91410728MA40HY472M

CE

2019-nCoV IgM / IgG Detection Kit (Colloidal Gold-Based)

523

深圳市华晨阳科技有限公司
Huachenyang (Shenzhen) Technology Co., Ltd.

914403006748496845

CE

COVID-19 IgM/IgG Antibody Diagnostic Kit (Colloidal Gold)

524

深圳市朴瑞生物科技有限公司
Shenzhen Poweray Biotechnology Co.,Ltd.

91440300MA5FBT316W

CE

FLU A & FLU B & COVID-19 Ag Rapid Test

525

深圳市中科先见医疗科技有限公司
Shenzhen CAS-Envision Medical Technology Co., Ltd.

91440300MA5F0J8N0D

CE

SARS-CoV-2 Antigen Rapid Detection kit

526

天津鸿宇泰生物科技有限公司
Hoyotek Biomedical Co.,Ltd.

91120118MA073P2G1C

CE

Corona Virus (COVID-19) Antigen Rapid Test (colloidal gold) (HYT-G01)
Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (colloidal gold) (HYT-G02)
Corona Virus (COVID-19) Combined (lgM/IgG/Neutralizing antibody) Rapid Test (colloidal gold) (HYT-G03)

527

杭州睿丽科技有限公司
Hangzhou Realy Tech Co., Ltd.
（持证公司：Arion Bio，Inc）

913301013219351652

CE

ArionBio PocketFIA COVID-19 Fluorescent Antigen (Ag) Rapid Test

528

浙江佳米生物医药科技有限公司
Zhejiang Jiami Biomedical Technology Co., Ltd.

91330421MA2JEN6G6L

CE

Famyhealth COVID-19 Ag Rapid Test (Colloidal Gold)

529

艾康生物技术（杭州）有限公司
Acon Biotech (Hangzhou) Co., Ltd.
（持证公司：ACON Laboratories, Inc.）

913301006091684447

U.S. FDA EUA

ACON SARS-CoV-2 IgG/IgM Rapid Test

530

杭州新脉生物科技有限公司
Hangzhou Eximio Biotech Co., Ltd.

91330110MA2J0B8H8X

CE

COVID-19 Antigen Rapid Test Kit
COVID-19 IgG/IgM Rapid Test Kit
Flu A+B Antigen & COVID-19 Antigen Rapid Test Kit

531

上海乐合生物科技有限公司
Shanghai Lehe Biotechnology Co.,Ltd.

91310114MA1GUDXR3K

CE

Rapid 2019-nCoV IgG/IgM Combo Test Card

532

上海伯杰医疗科技有限公司
Shanghai BioGerm Medical Technology Co., Ltd

91310115MA1H8NJF4W

CE

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold)

533

江西微升源生物科技有限公司
Microliters Biotech,Inc

91360800MA39BX1E1L

CE

SARS-CoV-2 & Influenza A/B (SC2Flu) Ag Triplex Fast (Colloidal Gold)

534

江苏科德生物医药科技有限公司
Jiangsu Code Biomedical Technology Co,.Ltd.

91320191067087542X

CE

CodeCheck SARS-CoV-2 RT-PCR Kit

535

江苏晶红生物医药科技股份有限公司
Genhon Biotecnology Corporation.

91320400346215922G

CE

 Novel Coronavirus (COVID-19) Antigen Detection Kit(Colloidal Gold-Based)

536

厦门希景医疗科技有限公司
Xiamen Hopegen Medical Technology Co.,Ltd.

91350211MA2XNTB721

CE

COVID-19 / influenza A virus / influenza B virus Antigen test Kit (colloidal gold)
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody test kit (colloidal gold)

537

浙江博纳生物科技有限公司
Zhejiang Bona Biotechnology Co., Ltd.

913306043501326444

CE

SARS-CoV-2 Antigen Rapid Test Kit

538

郑州科蒂亚生物技术有限公司
Zhengzhou Kodia Biotechnology Co.，Ltd.

914101003495270915

CE

SARS-COV-2 Nucleic Acid Detection Kit

539

福建克里贝尔生物技术有限公司
Fujian Clinbio Biotechnology Co., Ltd

91350525685075303M

CE

COVID-19 IgG/IgM Rapid Test
COVID-19 Antigen Rapid Test
COVID-19 Ag & Influenza Combo Rapid Test
SARS-CoV-2 IgG ELISA Kit
COVID-19 Neutralizing Antibody Combo Test
SARS-CoV-2 Neutralizing Antibody ELISA Kit

540

深圳微点生物技术股份有限公司
Micropoint Biotechnologies Co., Ltd.

91440300664196632N

CE

mLabs Ez SARS-CoV-2 Neutralization Antibody Test
mLabs Ez SARS-CoV-2 Neutralization Antibody Controls
COVID-19 Antigen Rapid Test (Latex)

541

杭州泰熙生物技术有限公司
Hangzhou Testsea Biotechnology Co.,Ltd.
（持证公司：Multibrands Trading (Suzhou) Co., Ltd.）

91330110MA27W8H87B

CE

SARS-CoV-2 Antigen Rapid Qualitative Test
SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold)

542

杭州聚成医疗用品有限公司
Hangzhou Jucheng Medical Products Co., Ltd.

91330185MA2H3HNN3P

CE

SARS-CoV-2 Ag Rapid Test Kit
COVID-19 Neutralizing Antibody Detection Kit
SARS-CoV-2 / Influenza Virus A/B Antigens Multiple Detection Kit

543

南京申基医药科技有限公司
Nanjing Synthgene Medical Technology Co., Ltd.
（持证公司：Multibrands Trading (Suzhou) Co., Ltd.）

91320114MA1X09DE0U

CE

SARS-CoV-2 Antigen Rapid Qualitative Test

544

广西桂林康力美医疗科技有限公司
Guangxi Guilin Kanglimei Medical Technology Co.,Ltd.

91450300MA5N8T8C9W

CE

SARS-COV-2 Antigen Rapid Test

545

广州蓝勃生物科技有限公司
Guangzhou Labsim Biotech Co.,Ltd.

91440116797381778C

CE

SARS-CoV-2 Angtigen Rapid Test Kit
(Time-Resolved Fluorescence)

546

广州迪澳生物科技有限公司
Guangzhou Deaou Bio-technology Co., Ltd.

914401166756910573

CE

COVID-2019 Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)
Instructions for COVID-2019 Virus Nucleic Acid Detection Kit

547

广州凯普医药科技有限公司
Guangzhou Hybribio Medicine Technology Ltd.

91440101MA59AAN02L

CE

COVID-19, Flu A and B Multiplex Real-time PCR Kit (HBRT-IFVab+COVID-19)

548

广州普世君安生物科技有限公司
Guangzhou Pluslife Technology Co., Ltd.

91440101MA5CQHJR7X

CE

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Test Kit (CRISPR-Lateral Flow Assay)

549

阿里生物技术泰州有限公司
Ali Biotechnology Taizhou Co.,Ltd

913212913211850859

CE

Novel Coronavirus (2019-nCoV) Detection Kit (colloidal gold immunochromatography)

550

百泰克泰州生物技术有限公司
Bioteke Taizhou Biotechnology Co., Ltd.

91321291MA24RJ1E4E

CE

Freeze-dried Novel Coronavirus (COVID-19) nucleic acid detection kit (Fluorescence PCR method)

551

江苏康为世纪生物科技股份有限公司
Jiangsu CoWin Biotech Co., Ltd.

91321291561773986P

CE

SARS-CoV-2 & Influenza A/B Nucleic Acid Test

552

南京黎明生物制品有限公司
Nanjing Liming Bio-Products Co.,Ltd.

9132010272837745XD

CE

System Device for SARS-CoV-2 Antigen Rapid Test
Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit）(detection for three genes)
SARS-CoV-2 IgM/IgG Antibody Rapid Test
SARS-CoV-2 & Influenza A/B Multiplex  Real-Time PCR Kit

553

盛世东唐江苏生物科技有限公司
Shengshi Dotop Jiangsu Biological Technology Co.,Ltd

91321291302164983H

CE

Virus Transport Infusion
Nucleic Acid Extraction Reagent
SARS-CoV2 (COVID-19) IgG/IgM TEST

554

杭州奥泰生物技术股份有限公司
Hangzhou Alltest Biotech Co.,Ltd.

91330101685842840Y

CE

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test ISIC-525
SARS-CoV-2 Neutralization Antibody Detection Kit
SARS-CoV-2 Neutralization Antibody Rapid Test
SARS-CoV-2 S-RBD Antibody Rapid Test
SARS-CoV-2 S-RBD IgG Antibody Rapid Test

555

杭州博拓生物科技股份有限公司
Hangzhou Biotest Biotech Co.,Ltd.
（持证公司：Citus Diagnostics Inc.）

9133010079969193XF

CE

COVID-19+Flu A&B+RSV Antigen Combo Rapid Test Cassette
COVID-19+Flu A&B+RSV+Adenovirus Antigen Combo Rapid Test Cassette
SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette

556

杭州莱和生物技术有限公司
Hangzhou Laihe Biotech Co.,Ltd.
（持证公司：Unisources Group LLC）

91330108589866519M

CE

Quickkit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Quickkit Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

557

杭州微策生物技术有限公司
VivaChek Biotech (Hangzhou) Co., Ltd.
  (持证公司：MED TRUST Handelsges.m.b.H.)

913301000743141922

CE

Wellion SARS-CoV-2 IgM/IgG ANTIBODY Rapid Test, 1ct
Wellion SARS-CoV-2 IgM/IgG ANTIBODY Rapid Test , 40ct
Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test, 1ct
Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test, 25ct

558

浙江安吉赛安芙生物科技有限公司
Zhejiang Anji Saianfu Biotech Co.,Ltd.

91330523MA2B3WE119

CE

SARS-COV-2 Ag & Influenza Combo Rapid Test
SARS-CoV-2 Neutralizing Antibody Rapid Test

559

浙江东方基因生物制品股份有限公司
Zhejiang Orient Gene Biotech Co., Ltd.
（持证公司：Healgen Scientific LLC）

913305007804719612

CE

SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
SARS-CoV-2 Ab & NAb Rapid Test Cassette (Whole Blood/Serum/Plasma)

560

重庆明道捷测生物科技有限公司
Chongqing M&D Biotechnology Co. Ltd

91500107MA617MP30X

CE

2019-nCoV Antigen Test Kit

561

艾特生物科技（深圳）有限公司
AiTe Bio-Technology Co.,Ltd.

91440300MA5F876J6Y

CE

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)

562

宝瑞源生物技术（北京）有限公司
Bao Ruiyuan Biotech(Beijing) Co.,Ltd.
（持证公司：Genabio Diagnostics Inc）

911101115657789526

CE

GenaBio SARS-CoV-2 Antigen Lateral Flow Test

563

北京热景生物技术股份有限公司
Beijing Hotgen Biotech Co.,Ltd

91110115777090586H

BfArM tentative approval

Coronavirus (2019-nCoV)-Antigentest（-有效期截至2021年6月2日）

564

迪瑞医疗科技股份有限公司
Dirui Industrial Co., Ltd

91220101605902656F

CE

2019-nCoV Total Antibody Detection Kit (Chemiluminescence Immunoassay)
2019-nCoV IgG/IgM Antibody Test Kit (Colloidal Gold)

565

格林生物医药科技（天津）有限公司
Glallergen Co. , Ltd.

91120222MA06BXY68B

CE

Novel Coronavirus (2019-nCoV) IgM / IgG Antibody Detection Kit(Colloidal gold immunochromatography)

566

杭州凯曼健康科技有限公司
Hangzhou Chemi Health Technology Co., Ltd.

91330108MA2CG9R05M

CE

Novel coronavirus (SARS-COV-2) Antigen Rapid Test Kit (Latex Method)
Novel coronavirus (SARS-COV-2) Antigen Rapid Test Kit (Fluorescence Method)

567

湖南圣辉生物科技有限公司
Sunbio Medical Co. Ltd

91430781MA4RK00322

CE

2019-nCoV/ InFluA/ InFluB Antigen Detection Kit (Fluorescence) - REF: SFJ9E0025
2019-nCoV/ InFluA/ InFluB Antigen Rapid Detection Kit (Lateral Flow Assay) - REF: SLK1E0025
2019-nCoV Antigen Rapid Detection Kit (Lateral Flow Assay) - REF: SLK2E0025
2019-nCoV Antigen Detection Kit (Fluorescence) - REF: SFK3E0025
2019-nCoV IgG/IgM Rapid Test Kit (Colloidal Gold) - REF: SCK4E0025

568

江苏美克医学技术有限公司
Jiangsu Medomics Medical Technology Co., Ltd
（持证公司：BioMedomics, Inc）

91320191MA1RA46X7Q

CE

SARS-CoV-2 Antigen Test Kit (LFIA)

569

江苏宜偌维盛生物技术有限公司
Innovation Biotechnology Co., Ltd. Jiangsu
（持证公司：AMPER,Inc）

91320118084172255Q

CE

AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)

570

量准（上海）医疗器械有限公司
Liangzhun (Shanghai) Medical Equipment Co.,Ltd.

91310116MA1JA0HH87

CE

SARS-CoV-2 Viral Particle Test Kit

571

普迈德（北京）科技有限公司
Pro-med （Beijing） Technology Co., Ltd.

91110114078587382R

CE

COVID-19 and COVID-19 Mutant Strain (B.1.1.7 Strain)Antigen Rapid Detection Kit (Colloidal Gold)
COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)
Influenza A+B and COVID-19 Antigen Combo Rapid Detection Kit (Colloidal Gold)
COVID-19 IgM/IgG Antibody Rapid Detection Kit (Colloidal Gold)
COVID-19 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold)

572

上海奥普生物医药股份有限公司
Shanghai Upper Bio-tech Pharma Co., Ltd.

91310115133295009P

CE

SARS-CoV-2 Test Kit (Real-time PCR)
Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test

573

深圳市康百得生物科技有限公司
Shenzhen Combined Biotech Co., Ltd.

91440300750472277F

CE

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
Influenza virus A/B and SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

574

深圳市梓健生物科技有限公司
Shenzhen Zijian Biotechnology Co.,Ltd.

91440300585615229B

CE

SARS-CoV-2 (COVID-19) Antibody Rapid Detection Kit (Lateral Flow Method)
SARS-CoV-2 (COVID-19 )Antigen Rapid Detection Kit (Lateral Flow Method)

575

沈阳医陆生物科技有限公司
Shenyang Medileading Biotech Co., Ltd.

91210113MA0TQJQ453

CE

2019-nCoV Neutralization Antibody(NAb) Detection Kit (Chemiluminescence Method)
2019-nCoV Antigen Detection Kit (Chemiluminescence Method)

576

天津鸿宇泰生物科技有限公司
Hoyotek Biomedical Co.,Ltd.
（持证公司：Multibrands Trading (Suzhou) Co., Ltd.）

91120118MA073P2G1C

CE

SARS-CoV-2 Antigen Rapid Qualitative Test
SARS-CoV-2/FluA/FluB Antigen Combo  Rapid Test Kit

577

威海康州生物工程有限公司
Weihai Kangzhou Biotechnology Engineering Co.,Ltd.
（持证公司：Multibrands Trading(Suzhou) Co.,Ltd）

913710000659164741

CE

SARS-CoV-2 Antigen Rapid Qualitative Test

578

武汉奥科博泰生物科技有限公司
Wuhan Aoke BoTai Biotechnology Co.,Ltd.

91420111303497085Q

CE

COVID-19 Neutralization Antibody Test (ELISA)

579

英诺特（唐山）生物技术有限公司
Innovita (Tangshan) Biological Technology Co., Ltd.

91130283568909612G

U.S. FDA EUA

Innovita 2019-nCoV Ab Test (Colloidal Gold)

580

浙江康特生物科技有限公司
Zhejiang Kangte Bio-Tech Co.,Ltd.

91330624731498033X

CE

2019-nCoV and Flu A/B Antigen Combo Rapid Test (Colloidal Gold)
2019-nCoV Antigen Rapid Test (Colloidal Gold)

581

基蛋生物科技股份有限公司
Getein Biotech,Inc.
（持证公司：Multibrands Trading (Suzhou) Co.,Ltd）

913201007360621166

CE

SARS-CoV-2 Antigen Rapid Qualitative Test

582

厦门宝太生物科技有限公司
Xiamen Biotime Biotechnology Co., Ltd.
（持证公司：Department of Health and Social Care ）

91350205671268681J

UK
 EUA

COVID-19 Self-Test（有效期至2021年6月22日）



Popular posts from this blog

After 70 years of age, language ability declines significantly, and more play and activity can delay it!

After 70 years of age, language ability declines significantly, and more play and activity can delay it!  70~74 years old is a turning point in the decline of language ability Playing more and more active can delay the decline of speech function Liu Chuqun, Professor of Jiangxi Normal University Decreased language fluency is an important speech performance of the elderly.  Studies have found that the age of 70 to 74 is an important turning point for the decline of verbal fluency, but a positive attitude and a healthy lifestyle can delay the decline of the elderly’s verbal fluency to a certain extent. After 70 years of age, language ability declines significantly Most of the elderly, especially the elderly, have these kinds of expressions: words that have no real meaning are repeated back and forth, lack of information to express, the words are inconsistent with what they think and form a verbal error, and the words cannot be remembered by the mouth (tip of tongue phenomenon), ...
Read more

European Medicines Agency investigates whether Johnson & Johnson COVID-19 vaccine is associated with thrombosis

European Medicines Agency investigates whether Johnson & Johnson COVID-19 vaccine is associated with thrombosis European Medicines Agency investigates whether Johnson & Johnson COVID-19 vaccine is associated with thrombosis. The European Medicines Agency said on the 9th that it is investigating whether the new crown vaccine developed by Johnson & Johnson Pharmaceuticals Co., Ltd. is associated with thrombosis. In the United States, four Johnson & Johnson vaccinators developed blood clots. This regulatory agency continues to investigate whether there is a causal link between the new crown vaccine developed by AstraZeneca Pharmaceuticals in the United Kingdom and the presence of blood clots in the vaccinators, and it has also found that some vaccinators have other diseases. Thrombosis associated with Johnson & Johnson vaccine? The European Medicines Agency said in a report on the 9th that four Johnson & Johnson vaccine vaccinators in the United States had severe t...
Read more

Medical news update on March 27 2022

  Medical news update on March 27 2022 Drugs News GlaxoSmithKline anti-HIV injectable drug gets the latest FDA approval!  7 mins ago GlaxoSmithKline anti-HIV injectable drug gets the latest FDA approval!   GlaxoSmithKline's anti-HIV injectable drug gets the latest FDA approval! Direct... Cancers Immunotherapy News Tumors How about patients now after CAR-T cell infusion ten years ago?  8 mins ago How about patients now after CAR-T cell infusion ten years ago?   How about patients now after CAR-T cell infusion... Cancers News Stem Cells Cell Stem Cell: Do Human Stem Cells Contain Oncogenic Mutations?  10 mins ago Cell Stem Cell: Do Human Stem Cells Contain Oncogenic Mutations?   Cell Stem Cell: Do Human Stem Cells Contain Oncogenic... COVID-19 News Simultaneous infection with COVID-19 and influenza increases the risk of severe illness and death  11 mins ago Simultaneous infection with COVID-19 and influenza increases the risk of severe illness and d...
Read more