Vietnam MOH registration 240001791/PCBB-HCM

HbA1c Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng HbA1c
Vietnam flagVietnam·Risk Class TTBYT Loại B·HbA1c Reagent Kit AutoQuant·Meril Diagnostics Pvt. Ltd·Registered Aug 14, 2024
Registration details
Analysis ID
240001791/PCBB-HCM
Submission ID
000.00.19.H29-240320-0002
Product Type
HbA1c Reagent Kit AutoQuant
Company information
Product Owner
Meril Diagnostics Pvt. Ltd
Authorized Representative
CÔNG TY TNHH MERIL (VIỆT NAM)
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.
Dates and status
Registration Date
Aug 14, 2024
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About this record

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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