bioMérieux VIDAS® High Sensitive Troponin I (TNHS) - HSA Registration DE0502274
Access comprehensive regulatory information for bioMérieux VIDAS® High Sensitive Troponin I (TNHS) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0502274 and owned by BIOMERIEUX S.A.. The device was registered on October 18, 2018.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
VIDAS® High sensitive Troponin I is an automated quantitative test for use on the instruments of the VIDAS® family for the determination of human cardiac troponin I in human serum or plasma, using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® High sensitive Troponin I assay is intended to be used as an aid in the diagnosis of myocardial infarction (MI) and for the risk stratification of patients with symptoms suggestive of acute coronary syndrome (ACS) with respect to relative risk of all-cause mortality and major adverse cardiac events (MACE) consisting of myocardial infarction and revascularization, at 30 days. This assay is intended for use in clinical laboratories (centralized or decentralized) by qualified laboratory professionals.