Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Genetic Signatures). ARTG record, intended purpose, GMDN…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
The device is a qualitative molecular method for the detection of nucleic acid of bacterial targets. The kit utilises DNA, from stool samples isolated and treated using an HGS Sample Processing Kit. The device is intended as an aid in the diagnosis of gastrointestinal illness. It is an IVD intended to be used in pathology lab or similar by trained personnel.