IVD Department quantitative CK-MB testing - Vietnam Registration 2402948ĐKLH/BYT-HTTB
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 2402948ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo phụ lục, Theo 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.
Device Details
Registration Details
2402948ĐKLH/BYT-HTTB
000.00.04.G18-201228-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
1. STANDARD™ F CK-MB Control: The STANDARD™ F CK-MB Control is designed to control the performance of the STANDARD™ F CK-MB FIA and STANDARD™ F Analyzer. It is recommended to perform at least two levels of the control material concentration test regularly at the laboratory. Quality control testing must be performed according to the specified requirements and standard procedures of each laboratory. 2. STANDARD™ F CK-MB FIA: The STANDARD™ F CK-MB FIA is a fluorescent immunoassay for the quantitative determination of the concentration of the total CK-MB isoform in serum or whole blood of humans on the STANDARD™ F Analyzer, manufactured by SD BIOSENSOR. This test is intended for in vitro diagnosis and is aimed at assisting in the screening and monitoring of myocardial infarction (MI).
Dates and Status
Oct 22, 2024