IVD Department Quantitative CRP Testing
Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024- Analysis ID
- 2403597ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240823-0005
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- 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.
- Registration Date
- Nov 14, 2024
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