Device Dossier
Troponin IVDs
Device Dossier for Troponin IVDs (CT1242 - Troponin IVDs, Class 3, sponsor Abacus dx). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT1242 - Troponin IVDs
Intended purpose
The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.