Vietnam MOH registration 240002072/PCBB-HCM

Quantitative Amino Acid Branched Chain Analysis (BCAAs) Test Kit

VN: Bộ xét nghiệm định lượng axit amin chuỗi nhánh (BCAAs)

Neonatal MSUD Screening Assay

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zentech SA·Registered Sep 13, 2024

Registration details

Analysis ID: 240002072/PCBB-HCM
Submission ID: 000.00.19.H29-240905-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zentech SA
Manufacturer Country: Theo theo phụ lục
Product Owner: Zentech SA
Authorized Representative: CÔNG TY TNHH GAM MA VIỆT BỈ

Technical details

Intended Use: The quantitative analysis of branched-chain amino acids (BCAAs) in the dried blood spot sample of newborns on the 903 or 226 paper. Medical professionals use the test to screen for the disorder known as Maple Syrup Urine Disease (MSUD). The test is performed on an automated or semi-automated system.

Dates and status

Registration Date: Sep 13, 2024

About this record

Access comprehensive regulatory information for Quantitative Amino Acid Branched Chain Analysis (BCAAs) 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 240002072/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.

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