Device Dossier
Reagent red blood cell IVDs
Device Dossier for Reagent red blood cell IVDs (CT886 - Reagent red blood cell IVDs, Class 3, sponsor Grifols). ARTG record, intended purpose, GMDN…
- GMDN category: CT886 - Reagent red blood cell IVDs
- Sponsor: Grifols
Intended purpose
Mi(a)-Cyte 0.8% is used in a qualitative test method in gel technique for the detection of unexpected antibodies in human blood samples. These tests are intended for transfusional or investigational practices and for prenatal and perinatal immunohematology studies. This reagent should be used with Grifols gel cards containing Anti-Human globulin reagents (Anti-IgG or Anti-IgG, -C3d polyspecific). For use in the manual method or with automated instruments.