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BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

China·CN-MF-000019125

Last updated September 18, 2026

What BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC makes

The company manufactures rapid diagnostic test kits for infectious disease markers, cardiac biomarkers, and hematological indicators, primarily using fluorescence immunoassay (FIA) technology. These include tests for cardiac troponin T, C-reactive protein, D-dimer, interleukin-6, and brain natriuretic peptide, as well as antigen and antibody assays for COVID-19 and SARS-CoV-2 variants. Additional offerings cover reproductive health markers like anti-Müllerian hormone and fecal occult blood detection. Nucleic acid testing for COVID-19 via fluorescence PCR is also part of the portfolio.

The device portfolio falls under in vitro diagnostic (IVD) classifications, including general IVD devices and those designated for self-testing. These products are registered in the EU’s eudamed database, a centralised system for tracking medical devices across the European Economic Area. The manufacturer is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: No.7, Yan Qi He, Xi Yi Rd., Huai Rou District,, Beijing, China
Website: en.keweidiagnostic.com
This website did not respond when we last checked — the domain may no longer be active. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 133 1150 3327
PRRC Contact: Baojun Wang
EUDAMED SRN: CN-MF-000019125
FDA FEI Number: —
DUNS Number: —

Catalogue (39)

Device	Model / Reference	Registries	Class	Status
Cardiac Troponin T Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Anti-Müllerian Hormone Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
C-Reactive Protein Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
SARS-COV-2/FIuA/FIuB Antigen Combo Rapid Test Kit	25Tests/kit	EUDAMED	IVD General	Active
COVID-19 IgG/IgM Antibody Rapid Test Kit	25Tests/Kit	EUDAMED	IVD General	Active
D-Dimer Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Interleukin-6 Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Fecal Occult Blood Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Amino Terminal pro Brain Natriuretic Peptide Rapid Test Kit(FIA)	25Tests/kit	EUDAMED	IVD General	Active
COVID-19 Antigen ELISA Test Kit	96Tests/Kit	EUDAMED	IVD General	Active
Brain Natriuretic Peptide Rapid Test Kit (FIA)	25Tests/kit	EUDAMED	IVD General	Active
COVID-19 nucleic acid Test kit (fluorescence PCR)	50Tests/Kit	EUDAMED	IVD General	Active
Procalcitonin Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Neutrophil Gelatinase Associated Lipocalin Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Multiple Rapid Real-Time PCR kit for Detection of A E gene and Omicron mutation of SARS-CoV-2	48Tests/kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit	1Test/Kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit（Oral Saliva）	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 Ab Rapid Test Kit（WB/Serum/Plasma）	25Tests/kit	EUDAMED	IVD General	Active
COVID-19 Neutralization Antibody ELISA Test	96Tests/kit	EUDAMED	IVD General	Active
25-OH Vitamin D Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit（Oral Saliva）	5Tests/Kit	EUDAMED	IVD General	Active
Kidney Injury Molecule 1 Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Myoglobin Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 Neutralization Antibody Rapid Test Kit	25Tests/kit	EUDAMED	IVD General	Active
Helicobacter Pylori Antigen Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Glycosylated Hemoglobin Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Multiple Real-Time PCR kit for Detection of SARS-CoV-2	48Tests/kit	EUDAMED	IVD General	Active
COVID-19 Ab Test Kit（ELISA）	96Tests/kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit	5 Tests/kit	EUDAMED	IVD devices for self-testing	Active
Cardiac Troponin I Rapid Test Kit (FIA）	25Tests/Kit	EUDAMED	IVD General	Active
Serum Amyloid A Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
Multiple Real-time PCR kit for Detection of Respiratory Viruses	25Tests/Kit	EUDAMED	IVD General	Active
Nucleic Acid Detection Kit for Human Papillomavirus 1618 and other 12 High-Risk Genotyping	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit	5Tests/Kit	EUDAMED	IVD General	Active
Creatine Kinase Isoenzymes (CK-MB) Rapid Test Kit (FIA)	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 IgM Antibody ELISA Test Kit	96Tests/kit	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 IgG/IgM Ab Rapid Test Kit	25Tests/Kit	EUDAMED	IVD General	Active
COVID-19 IgG Antibody ELISA Test Kit	96Tests/kit	EUDAMED	IVD General	Active

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