Troponin IVDs - ARTG 301443
Access comprehensive regulatory information for Troponin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 301443 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Immunotech SAS a Beckman Coulter Company in France. The device registration started on March 30, 2018.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The Access hsTnI assay and calibrator systems are a chemiluminescent immunoassay for high sensitivity quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).