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In vitro diagnostic medical devices
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Infectious immunology - rapid tests & point of care
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Virology - rt & poc - other
Virology - rt & poc - other
W0105099099
641 devices
COVID-19(SARS-CoV-2) Antigen Test Kit
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen IFU version 2022-01
Gold Probe Diagnostic Biotechnology Inc. MF
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test
Vivachek 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
SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA)
Jiangsu Medomics Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory pathogens nucleic acid easyPCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
EU-TDA-FI-20642-800030-2025-1
Active
Valid to Mar 2030
SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method)
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Strep A Antigen Rapid Test Cassette (Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Human Papillomavirus (HPV) Antigen Rapid Test Kit (Immunochromatography)
Labnovation Technologies, Inc.
·
,
China
IVD General
CE/IVDD
Zika NS1 Antigen Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit（Oral Saliva）
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Anbio Biotech
Anbio (Xiamen) Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
SARS-CoV-2 nucleic acid easyPCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
KaiBiLi COVID-19 Antigen
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Bio·Firm
Zhejiang Wantaifu Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Noroviruses Rapid Test Cassette(Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Neutralization Antibody Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
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