Quantitative Troponin I Test Kit - Vietnam Registration 2400629ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400629ĐKLH/BYT-HTTB
000.00.04.G18-220629-0006
VIDAS High sensitive Troponin I
415386
Technical Details
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
May 10, 2024