IVD Marker for Rheumatoid Arthritis: CRP, ASO - Vietnam Registration 240002764/PCBB-HN
Access comprehensive regulatory information for IVD Marker for Rheumatoid Arthritis: CRP, ASO in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002764/PCBB-HN and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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Device Details
Registration Details
240002764/PCBB-HN
000.00.19.H26-241002-0033
Theo theo phụ lục
Theo phụ lục
Technical Details
1. CRP: CRP test is an in vitro diagnostic medical device used by medical specialists to quantify the concentration of C-Reactive Protein (CRP) in human serum and plasma by the turbidimetric immunoassay method, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of CRP is used in the support of diagnosis and monitoring of the inflammatory process. 2. ASO: ASO test is an in vitro diagnostic medical device used by medical specialists to quantify Anti-Streptolysin O (ASO) in human serum by the turbidimetric immunoassay method, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of ASO antibodies is used in the support of diagnosis of the condition of infection with group A Streptococcus previously.
Dates and Status
Oct 15, 2024