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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
Adenovirus Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Flu A & Flu B&Respiratory Syncytial Virus&Adenovirus Antigen Rapid Test Cassett…
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)
Shanghai BioGerm Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
VIRAPID® ROTA/ADENO Ag
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Simple Rota-Adeno / Stick Rota-Adeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Bio·Firm
Zhejiang Wantaifu Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)
Salofa Oy
·
,
Finland
IVD General
CE/IVDD
Chikungunya Test Device (Serum +2 more)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Neutralizing antibody Rapid Test Kit
Triplex International Biosciences (China) Co., LTD.
·
,
China
IVD General
CE/IVDD
COVID-19 Ab Rapid Test Kit（WB/Serum/Plasma）
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Adenovirus Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
2019-nCoV Antigen Test (Lateral Flow Method)
Zhongshan Bio-Tech 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
COVID-19 IgM Antibody ELISA Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assa…
Bioteke Corporation (Wuxi) Co., Ltd.
·
,
China
Class C
CE/IVDR
EU-TDA-FI-43117-800031-2025
Active
Valid to May 2030
H.pylori Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
SFTSV IgG/IgM Test Kit (Serum +2 more)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
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