Device Category Dossier

CT881 - Red and white cell metabolic enzyme and haemolysis IVDs

Device Category Dossier for CT881 - Red and white cell metabolic enzyme and haemolysis IVDs. Australian ARTG records, sponsors, device class — compiled…

Red and white cell metabolic enzyme and haemolysis in vitro diagnostic devices are intended for the qualitative and/or quantitative determination of white and red cell metabolic enzymes and cellular membrane integrity in clinical specimens. These devices are used to assess metabolic function and cellular integrity in blood samples, supporting the evaluation of red and white blood cell health.