Device Dossier

Haematology full blood count IVDs

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

Intended purpose

These are IVDs that are intended to be used for the qualitative and/or quantitative haematological determination of measured and/or calculated whole blood cell parameters. Erythrocyte lytic agent is for quantitative determination of hemoglobin, and the counting, sizing and optical measurement of leukocytes. The isotonic buffered diluent is used in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.

TGA Public Summary