Vietnam MOH registration 2301815ĐKLH/BYT-HTTB

IVD Department quantitative Creatine kinase MB

VN: Bộ IVD xét nghiệm định lượng Creatine kinase MB

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 30, 2023

Registration details

Analysis ID: 2301815ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-221027-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: - CK-MB SL is an in vitro diagnostic test used to determine the concentration of creatine kinase MB (CK-MB) in human serum and plasma samples on an analyzer or semi-automatic analyzer. This in vitro diagnostic device is intended for professional use. - CK-MB Control: This in vitro diagnostic reagent is intended to control the performance of the ELITech Clinical Systems CK-MB test. It is intended for professional use.

Dates and status

Registration Date: Dec 30, 2023

About this record

Access comprehensive regulatory information for IVD Department quantitative Creatine kinase MB 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 2301815ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.

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