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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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2403569ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403569ĐKLH/BYT-HTTB
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Device Details

Drug Test for Quantitative Analysis of Catalytic Activity of the Creatine Kinase MB Isoenzyme
VN: Thuốc thử xét nghiệm định lượng hoạt tính xúc tác của tiểu đơn vị creatine kinase MB
Risk Class TBYT Loại C

Registration Details

2403569ĐKLH/BYT-HTTB

000.00.04.G18-240901-0002

CKMB

08057486190

Company Information

GERMANY

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