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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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Other virology rt & poc
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Virology - rt & poc - other
Virology - rt & poc - other
W0105099099
641 devices
Capilia Strep A 20T/Box
TAUNS Laboratories, Inc.
·
,
Japan
IVD General
CE/IVDD
Rotavirus Antigen Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit
Jiangsu Bioperfectus Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monkeypox virus nucleic acid real-time PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Neutralizing Antibody Rapid Test
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Strep. pneumoniae Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Rapid Flu A&B+RSV+Adeno Antigen Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
V76 092305 0014
Active
Valid to Apr 2030
Rapid SARS-CoV-2 Antigen Test Card
BioDetect（Xiamen）Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Norovirus Rapid Test Cassette (Feces)
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19(SARS-CoV-2) Antigen Test Kit
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Accu-Tell® COVID-19 Antigen Cassette (Saliva)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monkeypox Virus Ag Test Kit (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
TruVue
BioFynder Limited
·
,
United Kingdom
IVD General
CE/IVDD
Novel coronavirus (2019-nCoV) nucleic acid detection kit (Fluorescent PCR metho…
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Ki
Jiangsu Bioperfectus Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monkeypox Virus Real Time PCR Kit
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Anbio Biotech
Anbio (Xiamen) Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
TruVue
BioFynder Limited
·
,
United Kingdom
IVD General
CE/IVDD
Biosynex Combo Covid-Flu-Rsv Bss
BIOSYNEX Swiss SA
·
,
Switzerland
IVD General
CE/IVDD
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