CK-MB Quantitative Testing Control Reagent Kit - Vietnam Registration 2402547ĐKLH/BYT-HTTB
Access comprehensive regulatory information for CK-MB Quantitative Testing Control Reagent Kit 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 2402547ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Products Limited. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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Device Details
Registration Details
2402547ĐKLH/BYT-HTTB
000.00.04.G18-210719-0012
IMMULITE/ IMMULITE 1000 CK-MB (Name on Label: IMMULITE/IMMULITE Systems 1000 CK-MB)
10381016/ LKMB1
Technical Details
To be used in in vitro diagnostic with the IMMULITE and IMMULITE 1000 Analyzers - to measure the quantitative isoenzyme MB of creatine kinase (CK-MB) in heparin-anticoagulated blood or serum, as a supportive measure in the management of patients and in the risk assessment of myocardial infarction.
Dates and Status
Aug 30, 2024