Vietnam MOH registration 2403573ĐKLH/BYT-HTTB

Quantitative Troponin I Test Card

VN: Thẻ xét nghiệm định lượng Troponin I

Vietnam·Risk Class TBYT Loại C·Quidel Triage® Troponin I Test·Quidel Cardiovascular Inc.·Registered Nov 14, 2024

Registration details

Analysis ID: 2403573ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240828-0015
Product Type: Quidel Triage® Troponin I Test
Product Code: 98600EU

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® Troponin I Test is a fluorescent immunoassay used with the Quidel Triage Meters to rapidly quantify the concentration of troponin I in whole blood and EDTA-anticoagulated blood samples. The test is used as a supportive diagnostic tool for myocardial infarction.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Quantitative Troponin I 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 2403573ĐKLH/BYT-HTTB and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN TẬP ĐOÀN BM GROUP.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.