Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor C R Kennedy & Co). ARTG record,…

Intended purpose

Device consisting of reagent with colour indicator to test for Helicobacter Pylori urease activity in biopsy samples taken from a patient's stomach during a gastroscopy procedure.

TGA Public Summary