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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
Mumps Virus IgM Ab Rapid Test Kit
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)
Jiangsu Medomics Medical Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
EU-TDA-FI-06912-800035-2025-1
Active
Valid to Jan 2030
Reagena POC PUUMALA IgM
Reagena Oy
·
,
Finland
IVD General
CE/IVDD
Human Papillomavirus (HPV) Antigen Test Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
Zika Antigen Assay Kit(Colloidal gold)
Avioq Bio-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
H.pylori Rapid Test Kit (Colloidal Gold Method)
Farmasino Medical 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
SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Malaria Rapid Test Kit (Colloidal Gold Method)
Farmasino Medical Co., Ltd
·
,
China
IVD General
CE/IVDD
Monkeypox Virus IgG Test Kit (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Aidian LF SARS-CoV-2 Ag Test
Aidian Oy
·
,
Finland
IVD General
CE/IVDD
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD for self-testing
CE/IVDD
biotical Enterovirus Card (+PC +NC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
Norovirus GI/GII Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test
Xiamen Wiz Biotech 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
Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)
Salofa Oy
·
,
Finland
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）
Shenzhen Microprofit Biotech Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
Bio·Firm
Zhejiang Wantaifu Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
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