Device Dossier
Streptococcus IVDs
Device Dossier for Streptococcus IVDs (CT798 - Streptococcus IVDs, Class 3, sponsor Cepheid Holdings). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT798 - Streptococcus IVDs
Intended purpose
Qualitative in vitro diagnostic test for the detection of Group A Streptococcus in throat swab specimens from patients with signs and symptoms of pharyngitis. The test can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis and is not intended to monitor treatment for Group A Streptococcus infections.