Device Dossier
Bacterial infectious disease IVDs
Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Tri-Med Distributors). ARTG record,…
- GMDN category: CT353 - Bacterial infectious disease IVDs
- Sponsor: Tri-Med Distributors
Intended purpose
dryCLO Rapid Urease test is used for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic patients.