Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Cepheid Holdings). ARTG record, intended purpose, GMDN…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
The CT/NG Assay is a qualitative in vitro real-time PCR test for the automated and rapid detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)to aid in the diagnosis of chlamydial and/or gonorrheal urogenital disease.