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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
COVID-19/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
China
Class C
CE/IVDR
×2
Active
Valid to Jan 2031
COVID-19 & Influenza A+B Antigen Combo Rapid Test
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card
Xiamen Boson 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
Influenza A/B/RSV Combo Test Kit (Fluorescence Immunochromatographic Assay)
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rapid nCoV & FluA/B Ag Test Kit (Colloidal Gold)
Shenzhen Huian Biosci Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
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