IVD Department quantitative Creatine kinase MB - Vietnam Registration 2301815ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2301815ĐKLH/BYT-HTTB
000.00.04.G18-221027-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
- 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
Dec 30, 2023