Device Dossier

Haematology calibrator/control IVDs

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

Intended purpose

Control and calibrator kits used for the purpose of verifying the performance of associated IVD reagents for haemoglobin species and variant haemoglobins. For in vitro diagnostic laboratory use only.

TGA Public Summary