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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
Rapid Rubella IgG/IgM Combo Test
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory pathogens antigen combo test
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit（Colloidal Gold） -for self-testing
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
COVID-19 Neutralization Antibody IFU version 2021-01
Gold Probe Diagnostic Biotechnology Inc. MF
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Adenovims (ADV) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cholera antigen O1O139 Rapid Test Kit
Triplex International Biosciences (China) Co., LTD.
·
,
China
IVD General
CE/IVDD
COVID-19 nucleic acid Test kit (fluorescence PCR)
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold)
Jiangsu Konsung Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
1 control positivo Norovirus Gen I (sin test rápido)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
Rotavirus Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Capilia Adeno Neo 20T/Box
TAUNS Laboratories, Inc.
·
,
Japan
IVD General
CE/IVDD
Accu-Tell® Rotavirus/Adenovirus Combo Cassette(Feces)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
Shenzhen Microprofit Biotech Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)
Zhongshan Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood +2 more)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Simple RespirAdeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
HCG Pregnancy Test (Colloidal Gold)
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
IVD for self-testing
CE/IVDR
V76 003706 0007
Active
Valid to Aug 2030
CE/IVDD
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