Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Infectious diseases
/
Infectious immunology - rapid tests & point of care
/
Multiple pathogens - rt & poc
/
Coronavirus / influenza - rt & poc
Coronavirus / influenza - rt & poc
W0105090601
68 devices
Devices
Dynamiker COVID-19/Influenza A+B Ag Combo Rapid Test
Dynamiker Biotechnology (Tianjin) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
SARS-CoV-2 & Influenza A/B Detection Kit (Fluorescence PCR)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/MDR
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
COVID-19/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
CN
Class C
CE/IVDR
6211186CE01
Active
Valid to Jan 2031
CE/IVDR
6211186TD01
Active
Valid to Jan 2031
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
COVID-19/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
CN
Class C
CE/IVDR
6211186CE01
Active
Valid to Jan 2031
CE/IVDR
6211186TD01
Active
Valid to Jan 2031
Smart Rapid COVID-19 & Flu A/B Ag Test Device
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
Boiron Test & Care
Suny (Xiamen) Biotechnology Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
Biosynex Combo Covid-Flu Bss
BIOSYNEX Swiss SA
·
,
CH
IVD General
CE/IVDD
Rapid COVID-19+Influenza Antigen Test
Healgen Scientific Limited Liability Company
·
,
US
IVD General
FDA 510(k)
K232377
Active
Cleared 19 Apr 2024
CE/IVDD
COVID-19 & Influenza A/B Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
SARS-CoV-2 & Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
StrongStep® System Device for SARS-CoV-2 & Influenza A/ B Combo Antigen Rapid T…
Nanjing Liming Bio-products Co. Ltd
·
,
CN
IVD General
CE/IVDD
AQ+Rapid SARS-CoV-19/ Flu Combo Test
InTec PRODUCTS, INC.
·
,
CN
IVD General
CE/IVDD
TruVue
BioFynder Limited
·
,
GB
IVD General
CE/IVDD
Fastep
Assure Tech. (Hangzhou) Co., Ltd.
·
,
CN
IVD for self-testing
FDA 510(k)
K233174
Active
Cleared 5 Feb 2024
CE/IVDD
AQ+Rapid SARS-CoV-19/ Flu Combo Test
InTec PRODUCTS, INC.
·
,
CN
IVD General
CE/IVDD
Influenza A/B/RSV Combo Test Kit (Fluorescence Immunochromatographic Assay)
Diasia Biomedical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
COVID-19&Influenza A+B Antigen Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Previous
Next