Device Dossier
Reagent red blood cell IVDs
Device Dossier for Reagent red blood cell IVDs (CT886 - Reagent red blood cell IVDs, Class 4, sponsor Immulab). ARTG record, intended purpose, GMDN…
- GMDN category: CT886 - Reagent red blood cell IVDs
Intended purpose
1. Antibody Screening 2. Antibody Identification 3. Reverse Grouping
Functional description
Agglutination and/or haemolysis of the reagent red blood cell, in one or more techniques demonstrates the presence of clinically relevant antibodies in patient serum/plasma samples.