IVD Department Quantitative HbA1c Testing - Vietnam Registration 230002725/PCBB-HCM

Access comprehensive regulatory information for IVD Department Quantitative HbA1c 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 230002725/PCBB-HCM and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Theo theo phụ lục, Theo phụ lục, 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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230002725/PCBB-HCM

Registration Details

Vietnam MOH Registration: 230002725/PCBB-HCM

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Device Details

IVD Department Quantitative HbA1c Testing

VN: Bộ IVD xét nghiệm định lượng HbA1c

Risk Class TTBYT Loại B

Registration Details

Analysis ID

230002725/PCBB-HCM

Submission ID

000.00.19.H29-231123-0017

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

-HbA1c Quantitative Test: Used for in vitro testing to determine the concentration of HbA1c in the whole blood - HbA1c Quantitative Test Calibration Standard: Used for in vitro testing to use the calibration procedure to determine the concentration of hemoglobin A1c (HbA1c) in blood in the form of blood for each automated method. - HbA1c Quantitative Test Control Material: Used for in vitro testing to use the quality control procedure to determine the concentration of hemoglobin A1c (HbA1c) in blood A1c (HbA1c) in blood for each automated turbidity measurement method.