IVD Department Quantitative CRP Testing - Vietnam Registration 2403597ĐKLH/BYT-HTTB

Access comprehensive regulatory information for IVD Department Quantitative CRP Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403597ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Theo theo phụ lục, Meril Diagnostics Pvt. Ltd, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2403597ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403597ĐKLH/BYT-HTTB

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Device Details

IVD Department Quantitative CRP Testing

VN: Bộ IVD xét nghiệm định lượng CRP

Risk Class TBYT Loại C

Registration Details

Analysis ID

2403597ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-240823-0005

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

CRPHS: In vitro test used to quantify the concentration of C-reactive protein (CRP) in human serum and plasma on the cobas system. The CRP test is used to detect and assess inflammatory disorders and related diseases, infections, and tissue damage. The high-sensitivity CRP test can also be used to support the evaluation of the risk of coronary artery disease in the future. When used to support other evaluation methods in the coronary artery disease workup laboratory, it can also be an independent predictive marker for recurrent events in stable coronary artery disease patients or in patients with acute coronary syndrome; CRP T Control N: CRPTControlN is used in quality control to assess the accuracy and precision of the quantitative methods specified in the value document.; C.f.a.s Proteins: C.f.a.s. (Calibrator for automated systems) Proteins are used to calibrate the quantitative methods of Roche on the Roche clinical chemistry analyzers as specified in the value document.