CRP Quantitative Testing Reagent
Vietnam·Risk Class TTBYT Loại C·CRPHS·Roche Diagnostics GmbH·Registered Nov 02, 2024- Analysis ID
- 2403174ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240806-0008
- Product Type
- CRPHS
- Product Code
- 05401607190
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer Country
- GERMANY
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- In vitro testing used to quantify the concentration of C-reactive protein (CRP) in human serum and plasma on the cobas111 system. The CRP test is used to detect and assess inflammatory disorders and related diseases, infections, and tissue damage. High-sensitivity CRP testing can also be used to support the evaluation of the risk of coronary artery disease in the future. When used to support other diagnostic methods in the coronary artery disease workup, it may also be an independent prognostic indicator of recurrent events in stable coronary artery disease patients or in patients with acute coronary syndrome.
- Registration Date
- Nov 02, 2024
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Access comprehensive regulatory information for CRP Quantitative Testing Reagent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403174ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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