Vietnam MOH registration 2400629ĐKLH/BYT-HTTB

Quantitative Troponin I Test Kit

VN: Bộ xét nghiệm định lượng Troponin I

Vietnam·Risk Class TTBYT Loại C·VIDAS High sensitive Troponin I·BIOMERIEUX SA·Registered May 10, 2024

Registration details

Analysis ID: 2400629ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220629-0006
Product Type: VIDAS High sensitive Troponin I
Product Code: 415386

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: FRANCE
Product Owner: BIOMERIEUX SA
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: VIDAS® High sensitive Troponin I is an automated quantitative test performed on VIDAS® instruments to determine the concentration of human cardiac troponin I from human serum or plasma samples, using the ELFA (Enzyme-Linked Fluorescence Assay) technique. The VIDAS® High sensitive Troponin I test is used to assist in the diagnosis of myocardial infarction (MI) and to stratify the risk in patients suspected of having acute coronary syndrome (ACS) in relation to the risk of death and major adverse cardiovascular events (MACE) including MI and revascularization, 30 days after the event. This test is performed in clinical laboratories (centralized or decentralized) by qualified laboratory personnel.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Quantitative Troponin I Test 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 2400629ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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