Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor PM Separations). ARTG…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
Intended purpose
The ClinMass® Complete Kit with order no. MS2000 is intended for the determination of homocysteine (total homocysteine) from human plasma or serum by LC-MS/MS. The ClinSpot® Complete Kit with order no. MS2100 is intended for the determination of homocysteine (total homocysteine) from dried blood spots (DBS) of human origin by LC-MS/MS.