ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood

Conducting the ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood is to validate performance claims for precision of the ABL90 FLEX PLUS ctBil and FHbF parameters in neonatal whole blood while being influenced by testing environment that is representative of intended use environment, site variability, intended use testing environment and operator variability in a Point-of-Care (POC) setting. The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS. The study is being conducted in Denmark and in total, a minimum of 54 subjects are to be enrolled to provide successful measurement values from 3 different sites.