Device Dossier
Multiple infectious organism IVDs
Device Dossier for Multiple infectious organism IVDs (CT923 - Multiple infectious organism IVDs, Class 3, sponsor Immunexpress). ARTG record, intended…
- GMDN category: CT923 - Multiple infectious organism IVDs
Intended purpose
The SeptiCyte® RAPID is intended to be used for the quantitative and/or qualitative determination of immunological analytes (white blood cell gene expression) in peripheral blood as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in adult and paediatric patients suspected of sepsis. The SeptiCyte RAPID test is for in-vitro diagnostic use on the Biocartis IdyllaTM System and is intended to be used by trained healthcare professionals in a hospital laboratory setting only.