Device Dossier

- Creatine kinase IVDs

Device Dossier for - Creatine kinase IVDs (CT831 - Creatine kinase IVDs, Class 3, sponsor Ortho-Clinical Diagnostics). ARTG record, intended purpose,…

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.

TGA Public Summary