Device Dossier
Creatine kinase IVDs
Device Dossier for Creatine kinase IVDs (CT831 - Creatine kinase IVDs, Class 3, sponsor Abacus dx). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT831 - Creatine kinase IVDs
Intended purpose
The RAMP CK-MB Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure CK-MB levels in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP CK-MB Assay is not intended to monitor reperfusion patients. The RAMP CK-MB Assay is intended to be used only to prioritize patient management for those suspected of AMI.