Cardiac Troponin I (TnI) Quantitative Testing Card - Vietnam Registration 2402638ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Cardiac Troponin I (TnI) Quantitative Testing Card 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 2402638ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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.
Device Details
Registration Details
2402638ĐKLH/BYT-HTTB
000.00.04.G18-201228-0016
STANDARD™ F TnI FIA
F-TNI
Technical Details
STANDARD™ F TnI FIA is a fluorescent immunoassay for the quantitative determination of the total concentration of cardiac Troponin I (cTnI) in serum and whole blood samples from patients, as performed on the Standard™ F Analyzer manufactured by SD Biosensor. This test is intended for in vitro diagnostic use and is intended to support the screening and monitoring of acute myocardial infarction (AMI).
Dates and Status
Sep 30, 2024