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In vitro diagnostic medical devices
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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
Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Covid-19&Flu A/B Fia
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Zika IgM/IgG Rapid Test (Whole Blood +2 more)
Safecare Biotech (Hangzhou) 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
Adenovirus Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
Yellow Fever Antigen Test Kit (Serum +2 more)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus and Adenovirus Combo Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class B
CE/IVDR
HAV IgM Rapid Test Cassette(Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HPVix
Abcerion Diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
Norovirus Antigen FIA Test (Feces)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit
Shanghai BioGerm Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Zika Virus IgG/IgM Rapid Test Kit (Colloidal Gold)
Biobase Poct Co., Ltd
·
,
China
IVD General
CE/IVDD
Multiple Real-Time PCR kit for Detection of SARS-CoV-2
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Norovirus kasetki 20 szt.
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
One Step Rotavirus Test
Equinox Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chikungunya IgG/IgM Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenovirus IgM Ab Rapid Test Kit
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Ab Test Kit（ELISA）
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Norovirus Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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