Device Dossier
Bacterial infectious disease IVDs
Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Vitramed). ARTG record, intended…
- GMDN category: CT353 - Bacterial infectious disease IVDs
- Sponsor: Vitramed
Intended purpose
The Heliprobe BreathCard is used to collect and store CO2 from the 14C -urea breath test (UBT) of the patient. The system is intended for diagnosis of Helicobacter pylori infection in the gastrointestinal tract (stomach and duodenum) by using non-invasive 14C-urea breath test. If the patient is infected with Helicobacter pylori, a part of the exhaled CO2 will contain C-14.