Quantitative CKMB, Troponin I, BNP Test Card - Vietnam Registration 2403718ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative CKMB, Troponin I, BNP Test Card 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 2403718ĐKLH/BYT-HTTB and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN TẬP ĐOÀN BM GROUP.
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Device Details
Registration Details
2403718ĐKLH/BYT-HTTB
000.00.04.G18-240828-0014
Quidel Triage® Cardio3 Panel
97400EU
Technical Details
The Quidel Triage® Cardio3 Panel is a fluorescent immunoassay test used with the Quidel Triage Meters to rapidly quantify the concentration of creatine kinase MB (CK-MB), Troponin I, and B-type natriuretic peptide (BNP) in whole blood and EDTA-anticoagulated blood samples. The Quidel Triage® Cardio3 Panel is used as a specialized test to support the diagnosis of myocardial infarction (myocardial injury) and to support the diagnosis and assessment of the severity of heart failure (also known as congestive heart failure) and to support risk stratification of heart failure patients and patients with acute coronary syndrome.
Dates and Status
Nov 19, 2024