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In vitro diagnostic medical devices
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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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Other multiple pathogens - rt & poc
Other multiple pathogens - rt & poc
W0105090699
137 devices
Rota/Adeno Ag Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Ama Dent
«Association of Medicine and Analytics» Company Limited
·
,
Russia
IVD General
CE/IVDD
SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19&Influenza A/B Antigen combo Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class B
CE/IVDR
COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Eleven Respiratory Pathogens Antigen Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class B
CE/IVDR
COVID-19 & Influenza A/B & Respiratory syncytial virus(RSV) Antigen Rapid Test
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class B
CE/IVDR
Twelve Respiratory Pathogens Antigen Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory Multiple Rapid Test (Flu A +4 more)
Diasia Biomedical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
POCBio Rota/Adenovirus Combo Rapid Test
Nexlab Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/FIu A&B/RSV/AdV Antigen Combo Rapid Test
Avioq Bio-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/RSV/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
China
Class C
CE/IVDR
×2
Active
Valid to Jan 2031
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