IVD Quantitative Prealbumin Test Kit - Vietnam Registration 240002502/PCBB-HN
Access comprehensive regulatory information for IVD Quantitative Prealbumin Test Kit 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 240002502/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
240002502/PCBB-HN
000.00.19.H26-240918-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
PREALBUMIN: Prealbumin is an in vitro diagnostic medical device used by healthcare professionals to quantify prealbumin in human serum by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of prealbumin is used in the diagnostic support of malnutrition conditions. PREALBUMIN CALIBRATOR: Prealbumin Calibrator is a liquid human serum based calibrator used in conjunction with the Prealbumin OSR6175 reagent to quantify prealbumin, using the Beckman Coulter AU/DxC AU automated analyzers.
Dates and Status
Sep 23, 2024