Vietnam MOH registration 240000065/PCBB-BYT

IVD Department quantitative oxalate testing

VN: Bộ IVD xét nghiệm định lượng oxalat

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·BioSystems S.A.·Registered Jun 24, 2024

Registration details

Analysis ID: 240000065/PCBB-BYT
Submission ID: 000.00.04.G18-240620-0011
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: BioSystems S.A.
Manufacturer Country: Theo theo phụ lục
Product Owner: BioSystems S.A.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: 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

Registration Date: Jun 24, 2024

About this record

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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