Device Dossier
Immunohaematology calibrator/control IVDs
Device Dossier for Immunohaematology calibrator/control IVDs (CT890 - Immunohaematology calibrator/control IVDs, Class 4, sponsor Grifols). ARTG record,…
- GMDN category: CT890 - Immunohaematology calibrator/control IVDs
- Sponsor: Grifols
Intended purpose
Immunohematology calibrator are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the ABO, Rhesus and K antigens, (ii) the determination of the appropriate ABO blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. The product is suitable for use with DG Gel technique, MDmulticard and conventional tube technique.
Functional description
Immunohematology calibrators are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the ABO, Rhesus and K antigens, (ii) the determination of the appropriate ABO blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. The product is suitable for use with DG Gel technique, MDmulticard and conventional tube technique