Device Dossier

Haemoglobin IVDs

Device Dossier for Haemoglobin IVDs (CT879 - Haematology calibrator/control IVDs, Class 2, sponsor Fresenius Kabi). ARTG record, intended purpose, GMDN…

Intended purpose

Device is designed for verification of the precision and accuracy of Hemoglobin analyser and Cuvettes

TGA Public Summary