Device Dossier
Haematology calibrator/control IVDs
Device Dossier for Haematology calibrator/control IVDs (CT879 - Haematology calibrator/control IVDs, Class 2, sponsor Becton Dickinson). ARTG record,…
- GMDN category: CT879 - Haematology calibrator/control IVDs
- Sponsor: Becton Dickinson
Intended purpose
Haematology controls and calibrators may be used individually or with in vitro diagnostic products to document, monitor methods and/or assign values for enumeration of reticulocytes or leucocytes in platelet products by flow cytometry; including but not limited to the dilution and staining process, method setup, and/or RBC/WBC enumeration.