Device Dossier
Creatine kinase IVDs
Device Dossier for Creatine kinase IVDs (CT831 - Creatine kinase IVDs, Class 3, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN category…
- GMDN category: CT831 - Creatine kinase IVDs
Intended purpose
IVDs that are intended to be used for the qualitative and/or quantitative determination of creatine kinase enzyme and its various forms in a clinical specimen