IVD Protein Complex: α-1 Acidglycoprotein, β-2 Microglobulin - Vietnam Registration 240002873/PCBB-HN
Access comprehensive regulatory information for IVD Protein Complex: α-1 Acidglycoprotein, β-2 Microglobulin 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 240002873/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
240002873/PCBB-HN
000.00.19.H26-241015-0020
Theo theo phụ lục
Theo phụ lục
Technical Details
1. α-1 Acidglycoprotein: The α-1 Acidglycoprotein test is an in vitro diagnostic medical device used by healthcare professionals to quantitate α-1 acidglycoprotein in human serum and plasma by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of α-1 acidglycoprotein is used in the diagnostic support of infection or acute inflammation. 2. β-2 Microglobulin: The β-2 Microglobulin test is an in vitro diagnostic medical device used by healthcare professionals to quantitate β-2 microglobulin in human serum and plasma by turbidimetric immunoassay, using the Beckman Coulter AU/DxC AU automated analyzers. The measurement of β-2 microglobulin is used in the diagnostic support of kidney disease or as a marker of change in the lymphocyte cell cycle.
Dates and Status
Oct 24, 2024