Device Category Dossier

CT845 - Clinical chemistry tumour marker IVDs

Device Category Dossier for CT845 - Clinical chemistry tumour marker IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

In vitro diagnostic devices that perform qualitative and/or quantitative determination of specific tumour markers in clinical specimens represent this device category, operating through laboratory-based measurement of molecular indicators associated with malignancy. These devices are used to aid in the diagnosis of cancer, monitor high-risk patients for cancer development, and support cancer management .