Drug Test for Quantitative Analysis of Catalytic Activity of the Creatine Kinase MB Isoenzyme - Vietnam Registration 2403569ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Drug Test for Quantitative Analysis of Catalytic Activity of the Creatine Kinase MB Isoenzyme in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403569ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403569ĐKLH/BYT-HTTB
000.00.04.G18-240901-0002
CKMB
08057486190
Technical Details
In vitro testing used to quantify the catalytic activity of the creatine kinaseMB (CK‑MB) monomer in human serum and plasma on various cobas systems.
Dates and Status
Nov 14, 2024

