Device Dossier
Troponin IVDs
Device Dossier for Troponin IVDs (CT1242 - Troponin IVDs, Class 3, sponsor Beckman Coulter). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT1242 - Troponin IVDs
Intended purpose
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).