CRP Quantitative Testing Reagent - Vietnam Registration 2403174ĐKLH/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 2403174ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Diagnostics GmbH, and 2 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.
Device Details
Registration Details
2403174ĐKLH/BYT-HTTB
000.00.04.G18-240806-0008
CRPHS
05401607190
Technical Details
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.
Dates and Status
Nov 02, 2024