Creatine Kinase MB Quantitative Standardized Reference Material - Vietnam Registration 2400654ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Creatine Kinase MB Quantitative Standardized Reference Material 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 2400654ĐKLH/BYT-HTTB and manufactured by Ortho-Clinical Diagnostics Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.
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Device Details
Registration Details
2400654ĐKLH/BYT-HTTB
19010949/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
(1) VITROS Chemistry Products CKMB Slides are used in in vitro diagnosis to quantify the activity of creatine kinase MB (CK-MB) in serum using the VITROS 250/350/5,1 FS, 4600, XT 3400 and VITROS 5600/XT 7600 biochemical assay systems. (2) VITROS Chemistry Products Calibrator Kit 6 is used in in vitro diagnosis to calibrate the VITROS 250/350/5,1 FS/4600/XT 3400 and VITROS 5600/XT 7600 biochemical assay systems when quantifying Cholinesterase (CHE) and Creatine Kinase MB (CKMB).
Dates and Status
May 10, 2024