Device Dossier
Streptococcus IVDs
Device Dossier for Streptococcus IVDs (CT798 - Streptococcus IVDs, Class 3, sponsor Aceso Diagnostics). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT798 - Streptococcus IVDs
Intended purpose
The Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens in throat swab specimens. For near-patient and laboratory professional in vitro diagnostic use only.