Device Category Dossier

CT1270 - Immunohaematology-related IVDs

Device Category Dossier for CT1270 - Immunohaematology-related IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Immunohaematology-related in vitro diagnostic devices are intended to be used alone or in combination with other IVDs to perform various immunohaematology-related tests and procedures, including agglutination detection and enhancing reagents and red cell preservative or storage solutions. These devices enable screening and identification of irregular antibodies and crossmatching in blood samples, including from patients undergoing specific therapeutic treatments that may complicate standard immunohaematological testing.