Device Dossier
Streptococcus IVDs
Device Dossier for Streptococcus IVDs (CT798 - Streptococcus IVDs, Class 3, sponsor Touch Biotechnology). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT798 - Streptococcus IVDs
- Sponsor: Touch Biotechnology
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. The test is intended to be used by health professionals or laboratory professionals at the point of care setting.