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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
Rapid HPIV Antigen Test
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
VivaDiag Monkeypox Virus IgM/IgG Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood +2 more)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Norovirus Antigen Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chikungunya IgG/IgM Rapid Test (Whole Blood +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 and Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescent PCR …
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Influenza A+B/COVID-19 Antigen Combined Rapid Test Kit (Colloidal Gold Method)
Farmasino Medical Co., Ltd
·
,
China
IVD General
CE/IVDD
Zika IgM/IgG Rapid Test(Serum/Plasma)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Zika IgG/IgM/NS1 Combo Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
hMPV Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cass…
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Bio·Firm
Zhejiang Wantaifu Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Adenovims (ADV) Antigen Rapid Test (Immunochromatographic Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Boiron
Anbio (Xiamen) Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Norovirus GI+GII Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class B
CE/IVDR
Hantavirus IgG/IgM Rapid Test (WB +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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