Device Category Dossier

CT831 - Creatine kinase IVDs

Device Category Dossier for CT831 - Creatine kinase IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Creatine kinase in vitro diagnostic devices are quantitative immunochromatographic tests that measure creatine kinase enzyme levels and its various isoforms in blood or plasma specimens . These devices aid in the rapid diagnosis of acute myocardial infarction by detecting elevated CK-MB levels in patients suspected of cardiac damage .