Device Dossier
Immunohaematology-related IVDs
Device Dossier for Immunohaematology-related IVDs (CT1270 - Immunohaematology-related IVDs, Class 3, sponsor Grifols). ARTG record, intended purpose,…
- GMDN category: CT1270 - Immunohaematology-related IVDs
- Sponsor: Grifols
Intended purpose
Darzalex (Anti-CD38), a multiple myeloma treatment, creates pan-reactivity of Reagent Red Blood Cells (RRBC) used for alloantibody identification. Grifols sCD38, is a protein reagent for the pre-treatment of plasma of patients receiving Darzalex therapy, in order to counteract Darzalex-mediated pan-reactivity without diluting the patient plasma significantly. This enables subsequent screening and identification of irregular antibodies in DG Gel and tube techniques, and crossmatch in DG Gel technique in plasma from patients undergoing Darzalex treatment. For use with the DG Gel System in the manual method and tube test.