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Phenylalanine Quantitative Test Kit - Vietnam Registration 240001392/PCBB-HCM

Access comprehensive regulatory information for Phenylalanine Quantitative Test Kit 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 240001392/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Wallac OY, Calbiotech Inc., and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
Vietnam MOH Registration: 240001392/PCBB-HCM
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Device Details

Phenylalanine Quantitative Test Kit
VN: Bộ xét nghiệm định lượng phenylalanine
Neonatal PKU Screening Assay
Risk Class TTBYT Loại B

Registration Details

240001392/PCBB-HCM

000.00.19.H29-240613-0021

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Zentech SA

Technical Details

The quantitative determination of phenylalanine (Phe) in dried blood spots from newborns on filter paper 903 or 226. Medical professionals use the test to screen for phenylketonuria (Phenylketo niệu). The test is performed on a semi-automatic or automatic system.

Dates and Status

Jul 08, 2024

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