IVD Department quantitative oxalate testing - Vietnam Registration 240000065/PCBB-BYT
Access comprehensive regulatory information for IVD Department quantitative oxalate testing 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 240000065/PCBB-BYT and manufactured by BioSystems S.A.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
240000065/PCBB-BYT
000.00.04.G18-240620-0011
Theo theo phụ lục
Theo phụ lục
Technical Details
1. OXALATE: A reagent used for quantitative determination of oxalate in human urine. The results obtained are very useful in the diagnosis of hyperoxaluria. The reagent is used on the BA biochemical analyzers of BioSystems or on other analyzers with similar performance characteristics. 2. OXALATE CONTROL URINE II: OXALATE CONTROL URINE II is intended for quality control in the clinical laboratory and provides suggested acceptable concentration ranges. It is intended for in vitro diagnostic use by the clinical laboratory staff.
Dates and Status
Jun 24, 2024