Manufacturer

Beijing Kewei Clinical Diagnostic Reagent

ChinaLegal entities : BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

Markets : Netherlands

EU representative : Lotus NL B.V. (Netherlands)

3 categories, 17 models including 17 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	COVID-19 Ab Rapid Test Kit（WB/Serum/Plasma）98/79 COVID-19 Ab Test Kit（ELISA）98/79 COVID-19 Antigen ELISA Test Kit98/79 COVID-19 Antigen Rapid Test Kit5 refs98/79 COVID-19 Antigen Rapid Test Kit（Oral Saliva）3 refs98/79 10 others COVID-19 IgG Antibody ELISA Test Kit98/79 COVID-19 IgG/IgM Ab Rapid Test Kit98/79 COVID-19 IgG/IgM Antibody Rapid Test Kit98/79 COVID-19 IgM Antibody ELISA Test Kit98/79 COVID-19 Neutralization Antibody ELISA Test98/79 COVID-19 Neutralization Antibody Rapid Test Kit98/79 COVID-19 nucleic acid Test kit (fluorescence PCR)98/79 Multiple Rapid Real-Time PCR kit for Detection of A E gene and Omicron mutation of SARS-CoV-298/79 Multiple Real-Time PCR kit for Detection of SARS-CoV-298/79 SARS-COV-2/FIuA/FIuB Antigen Combo Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori Antigen Rapid Test Kit (FIA)98/79	– 98/79	EUDAMED record Report an error
Infectious immunology - other	W0105900299	Multiple Real-time PCR kit for Detection of Respiratory Viruses98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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