Device Dossier

Haematology calibrator/control IVDs

Device Dossier for Haematology calibrator/control IVDs (CT879 - Haematology calibrator/control IVDs, Class 2, sponsor Abacus dx). ARTG record, intended…

GMDN category: CT879 - Haematology calibrator/control IVDs

Intended purpose

FETALtrol is an assayed, stabilized 3 level control set designed to validate and monitor the quality of procedures of Fetal Maternal Haemorrhage (FMH) testing. FETALtrol is compatible as a control for both manual (Kleihauer Bettke Methods) and flow cytometry methods

TGA Public Summary