HbA1c Quantitative Testing Drug - Vietnam Registration 240001791/PCBB-HCM

Access comprehensive regulatory information for HbA1c Quantitative Testing Drug 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 240001791/PCBB-HCM and manufactured by Meril Diagnostics Pvt. Ltd. The authorized representative in Vietnam is CÔNG TY TNHH MERIL (VIỆT NAM).

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Wuxi Biohermes Bio & Medical Technology Co., Ltd, Nanjing Norman BiologicaI Technology Co., Ltd., and 3 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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240001791/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240001791/PCBB-HCM

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Device Details

HbA1c Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng HbA1c

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240001791/PCBB-HCM

Submission ID

000.00.19.H29-240320-0002

Product Type

HbA1c Reagent Kit AutoQuant

Technical Details

Intended Use

The test drug is used to determine the percentage of HbA1c in human blood by the method of enhanced latex immune turbidimetry. - Ready-to-use liquid stabilized test drug - Multi-point calibration - Direct results (% HbA1c) from the analyzer - No need to measure total Hb on the AutoQuant 100 /100 Amara I 2001 /200 Excelus /400i /400.