CRP Quantitative Testing Reagent - Vietnam Registration 2403570ĐKLH/BYT-HTTB
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 2403570ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403570ĐKLH/BYT-HTTB
000.00.04.G18-240809-0010
CRPHS
05950864190
Technical Details
In vitro testing is used to quantify the C-reactive protein (CRP) in human serum and plasma on the cobas system. The CRP measurement is used to detect and assess inflammatory disorders and related diseases, infections, and tissue damage. The high-sensitivity CRP measurement 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 syndrome, it can also be an independent prognostic indicator of recurrent events in stable coronary artery disease patients or in the coronary artery disease syndrome.
Dates and Status
Nov 14, 2024