Device Dossier
Haematology calibrator/control IVDs
Device Dossier for Haematology calibrator/control IVDs (CT879 - Haematology calibrator/control IVDs, Class 2, sponsor Revvity). ARTG record, intended…
- GMDN category: CT879 - Haematology calibrator/control IVDs
Intended purpose
The kit is intended to be used as a control in isoelectric focusing on electrophoresis gels. Relative positions of hemoglobin variants A, F, S, and C in the control are used in monitoring assay performance acceptability and in qualitative identification of normal and variant hemoglobin in human blood samples. The kit is intended to be used by trained laboratory personnel.