Vietnam MOH registration 240000063/PCBB-BYT

Quantitative Bile Acid Test Reagent

VN: Thuốc thử xét nghiệm định lượng acid mật

Vietnam·Risk Class TTBYT Loại B·TOTAL BILE ACIDS·BioSystems S.A.·Registered May 30, 2024

Registration details

Analysis ID: 240000063/PCBB-BYT
Submission ID: 000.00.04.G18-240529-0012
Product Type: TOTAL BILE ACIDS
Product Code: 23551

Company information

Manufacturer: BioSystems S.A.
Manufacturer Country: 30. 08030 Barcelona
Product Owner: BioSystems S.A.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: The test drug is used for quantitative determination of total serum or plasma acid phosphatase concentration. The results obtained are very useful in supporting the diagnosis of some chronic liver diseases. The test is performed on the BA biochemical analyzers of BioSystems or on other analyzers with similar performance characteristics.

Dates and status

Registration Date: May 30, 2024

About this record

Access comprehensive regulatory information for Quantitative Bile Acid Test Reagent 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 240000063/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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