Vietnam MOH registration 2403718ĐKLH/BYT-HTTB

Quantitative CKMB, Troponin I, BNP Test Card

VN: Thẻ xét nghiệm định lượng CKMB, Troponin I, BNP

Vietnam·Risk Class TBYT Loại C·Quidel Triage® Cardio3 Panel·Quidel Cardiovascular Inc.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403718ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240828-0014
Product Type: Quidel Triage® Cardio3 Panel
Product Code: 97400EU

Company information

Manufacturer: Quidel Cardiovascular Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY CỔ PHẦN TẬP ĐOÀN BM GROUP

Technical details

Intended Use: 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

Registration Date: Nov 19, 2024

About this record

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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