Device Dossier
Creatine kinase IVDs
Device Dossier for Creatine kinase IVDs (CT831 - Creatine kinase IVDs, Class 3, sponsor Radiometer). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT831 - Creatine kinase IVDs
Intended purpose
IVDs used for the qualitative and/or quantitative determination of creatine kinase enzyme and its various forms in a clincial specimen. It is intended as an aid in the diagnosis.