Qualitative Troponin I Test - Vietnam Registration 2403401ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative Troponin I Test 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 2403401ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.
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Device Details
Registration Details
2403401ĐKLH/BYT-HTTB
000.00.04.G18-230523-0007
OnSite Troponin I Combo Rapid Test
R3002C
Technical Details
The OnSite Troponin I Combo Rapid Test is an immunoassay device, based on the principle of unidirectional flow, for qualitative detection of cardiac Troponin I (cTnI) and its complex in serum, plasma, or whole blood of humans at levels equal to or greater than 1 ng/mL. It is intended to be used as a screening test by a qualified individual, to support the diagnosis of acute myocardial infarction (AMI).
Dates and Status
Nov 06, 2024