Device Dossier
Streptococcus IVDs
Device Dossier for Streptococcus IVDs (CT798 - Streptococcus IVDs, Class 3, sponsor Hologic (Australia & New Zealand)). ARTG record, intended purpose,…
- GMDN category: CT798 - Streptococcus IVDs
Intended purpose
The Panther Fusion GBS assay is an automated in vitro diagnostic test utilising real-time PCR for detection of Group B Streptococcus DNA from either Lim or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18-24 hours incubation.