Device Dossier
Immunohaematology calibrator/control IVDs
Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 4, sponsor Immulab). ARTG record,…
- GMDN category: CT890 - Immunohaematology calibrator/control IVDs
Intended purpose
ImmuClone Rh-Hr Control is an in vitro diagnostic blood grouping reagent intended to be used as negative control for Rhesus antigen typing. Negative Control micro reagent is used for parallel testing with indirect coombs blood grouping antisera to indicate if the antisera could give a false positive result due to abnormalities of the sample such as autoantibodies, positive direct antiglobulin test or protein abnormalities. The Negative Control micro reagent is designed to be used as negative control in conjunction with the following reagents: Anti-Jk(a) micro, Anti-Jk(b) micro, Anti-Fy(a) micro, Anti Fy(b) micro, Anti-S micro, Anti-s micro, Anti-k micro and Anti-Cw micro.
Functional description
immuClone Rh-Hr Control is control reagent for the immuClone Rh reagents. The control is produced from selected donor sera without antibodies prepared in the same diluent containing all components as Rh reagents. The use of Rh-Hr Control is necessary for