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 AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I levels in human serum and plasma using the Access 2 and UniCel DxI Immunoassay System to aid in the diagnosis of myocardial infarction.