Device Dossier
Bacterial infectious disease IVDs
Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Leolex Health). ARTG record, intended…
- GMDN category: CT353 - Bacterial infectious disease IVDs
Intended purpose
A Rapid Test integrated Device intended for the collection of a throat swab specimen and its rapid analysis by a chromatographic immunoassay for the qualitative detection of Strep A antigen to aid in the diagnosis of Group A Streptococcal infection.