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
The Cepheid Xpert GBS is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens, using PCR) with. Xpert GBS Assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization.