Device Dossier

Immunohaematology calibrator/control IVDs

Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 3, sponsor Immulab). ARTG record,…

Intended purpose

The Coombs Control Serum is for use as a control to confirm the sensitivity of Coombs techniques and is for use in tube tests. The Anti-D Standards Kit is for use as a control to confirm the sensitivity of the Anti-Human Globulin test and is for use in Indirect Antiglobulin Tests.

TGA Public Summary