Device Dossier
Creatine kinase IVDs
Device Dossier for Creatine kinase IVDs (CT831 - Creatine kinase IVDs, Class 3, sponsor Beckman Coulter). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT831 - Creatine kinase IVDs
Intended purpose
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems.