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
The CLOtest rapid urease test (RUT) accurately and conveniently detects the urease enzyme of Helicobacter pylori in gastric mucosal biopsies. Its use is intended for the presumptive diagnosis of Helicobacter pylori infection. For in vitro diagnostic use.