Vietnam MOH registration 230000139/PCBB-HCM

CRP Quantitative Testing Reagent

VN: Thuốc thử xét nghiệm định lượng CRP
Vietnam flagVietnam·Risk Class TTBYT Loại B·CRPHS·Roche Diagnostics GmbH·Registered Jan 18, 2023
Registration details
Analysis ID
230000139/PCBB-HCM
Submission ID
000.00.19.H29-230113-0008
Product Type
CRPHS
Product Code
04628918190
Company information
Technical details
Intended Use
In vitro testing is used to quantify the C-reactive protein (CRP) in human serum and plasma on various systems, including the Roche/Hitachi cobas c. The CRP measurement is used to detect and assess various inflammatory disorders and related diseases, infections, and tissue damage. High-sensitivity CRP measurements 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
Registration Date
Jan 18, 2023
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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 B medical device is registered under number 230000139/PCBB-HCM and manufactured by Roche Diagnostics GmbH.

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