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IVD Department quantitative CK-MB testing - Vietnam Registration 2200184ĐKLH/BYT-TB-CT

Access comprehensive regulatory information for IVD Department quantitative CK-MB testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2200184ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including SD Biosensor, Inc., Theo phụ lục, and 2 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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2200184ĐKLH/BYT-TB-CT
Registration Details
Vietnam MOH Registration: 2200184ĐKLH/BYT-TB-CT
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Device Details

IVD Department quantitative CK-MB testing
VN: Bộ IVD xét nghiệm định lượng CK-MB
Risk Class TTBYT Loại C

Registration Details

2200184ĐKLH/BYT-TB-CT

000.00.04.G18-210914-0016

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Technical Details

Alinity c CK-MB Test is used to measure the kinetics of the CK-MB and CK-BB isoenzymes of creatine kinase in serum or plasma on the Alinity c analyzer. Alinity c CK-MB Calibrator is used to calibrate the CK-MB test on the Alinity c analyzer. Alinity c CK-MB Control is used only to assess the performance of the Alinity c CK-MB test on the Alinity c analyzer.

Dates and Status

Dec 27, 2022

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