Haematology calibrator/control IVDs

Intended purpose

These are IVDs that are intended to be used in testing to establish known points of reference and/or verify the performance of haematological assays. The DxH 500 Series Control is an assayed whole blood control designed to monitor values on multi parameter hematology cell counters. The DxH 500 Series Calibrator is designed for the determination of calibration factors for the DxH 500 Series Systems in conjunction with specific DxH 500 Series reagents.