Vietnam MOH registration 2402930ĐKLH/BYT-HTTB

IVD Department quantitative Troponin I in the heart

VN: Bộ IVD xét nghiệm định lượng Troponin I tim

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Immunotech S.A.S., A Beckman Coulter Company·Registered Oct 22, 2024

Registration details

Analysis ID: 2402930ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230818-0002
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Immunotech S.A.S., A Beckman Coulter Company
Manufacturer Country: Theo theo phụ lục
Product Owner: Immunotech S.A.S., A Beckman Coulter Company
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: 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

Registration Date: Oct 22, 2024

About this record

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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