Device Dossier

Haematology full blood count IVDs

Device Dossier for Haematology full blood count IVDs (CT878 - Haematology full blood count IVDs, Class 2, sponsor Becton Dickinson). ARTG record,…

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative haematological determination of measured and/or calculated residual leucocytes (rWBCs), red blood clells (rRBCs), and platelets (rPLTs) in human blood products using techniques such as flow cytometry.

TGA Public Summary