Device Dossier
Acquired genetic alteration IVDs
Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Vela Diagnostics). ARTG record, intended…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
Next-Generation Sequencing (NGS) based in vitro diagnostic oncology panels that simultaneously detect hot spot mutations in various genes that have previously demonstrated clinical relevance in the management of patients with various cancer types from clinical samples. These panels are used on Sentosa SX101 in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments.