Device Dossier

Immunohaematology calibrator/control IVDs

Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 4, sponsor Ortho-Clinical…

Intended purpose

IVDs that are intended to be used in testing to establish known points of reference and/or verify the perfomance of immunohaematological tests.

Functional description

The ORTHO CONFIDENCE™ WB Quality Control Kit is intended for use as qualitative controls to assure the reliability of basic blood bank serological reagents and automated/manual blood grouping systems using column agglutination techniques

TGA Public Summary