Device Category Dossier
CT929 - Acquired genetic alteration IVDs
Device Category Dossier for CT929 - Acquired genetic alteration IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.
- Device: 5415219A0270CC - Idylla EGFR Mutation Test
- Device: LeukoStrat CDx FLT3 Mutation Assay - Acquired genetic alteration IVDs
- Device: Oncomine™Dx Target Test
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: VENTANA HER2 Dual ISH DNA Probe Cocktail - Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: cobas® 4800 BRAF V600 Mutation Test - Acquired genetic alteration IVDs
- Device: therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
- Device: Acquired genetic alteration IVDs
In vitro diagnostic tests detect genetic alterations including gene mutations, sequence variations, and gene rearrangements using techniques such as high throughput parallel sequencing and multiplex polymerase chain reaction analysis on DNA or RNA extracted from tissue, blood, or bone marrow specimens. These tests serve as companion diagnostics to guide treatment selection and monitor disease burden in patients with cancers including non-small cell lung cancer, acute myelogenous leukaemia, and B-cell malignancies.