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IVD Department quantitative Troponin I in the heart - Vietnam Registration 2402930ĐKLH/BYT-HTTB

Access comprehensive regulatory information for IVD Department quantitative Troponin I in the heart 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 2402930ĐKLH/BYT-HTTB and manufactured by Immunotech S.A.S., A Beckman Coulter Company. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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2402930ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402930ĐKLH/BYT-HTTB
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Device Details

IVD Department quantitative Troponin I in the heart
VN: Bộ IVD xét nghiệm định lượng Troponin I tim
Risk Class TTBYT Loại C

Registration Details

2402930ĐKLH/BYT-HTTB

000.00.04.G18-230818-0002

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Immunotech S.A.S., A Beckman Coulter Company

Technical Details

Access hsTnI is a fluorescent immunoassay, bead-based test to determine the concentration of cardiac troponin I (cTnI) in human serum or plasma with high sensitivity, aimed at supporting the diagnosis of myocardial infarction (MI).

Dates and Status

Oct 22, 2024