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In vitro diagnostic medical devices
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Reagents
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Multiple pathogens - rt & poc
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Coronavirus / influenza - rt & poc
Coronavirus / influenza - rt & poc
W0105090601
68 devices
Influ A+B/ADV/RSV Ag 4-in-1 Test Panel
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Go…
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Vir…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Rapid nCoV & FluA/B Ag Test Kit (Colloidal Gold)
Shenzhen Huian Biosci Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
China
Class C
CE/IVDR
×2
Active
Valid to Jan 2031
SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Met…
Taizhou Cowingene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
POCBio COVID-19/Flu A&B Combo Rapid Test
Nexlab Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/Influenza A+B Ag Combo Rapid Test
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Influenza A/B/RSV Combo Test Kit (Fluorescence Immunochromatographic Assay)
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory Multiple Rapid Test
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)
Taizhou Cowingene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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