Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Pure Sponsor). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
Hybribio STD3 Real-time PCR Kit is designed for in-vitro qualitative detection of 3 sexually transmitted pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, and Ureaplasma urealyticum in male urethral secretions and female cervical exfoliated cells. It is used as an aid in diagnosis of Chlamydia, Gonorrhea and Ureaplasma in symptomatic (e.g. gonorrhoea and non-gonococcal urethritis, cervicitis, etc) individuals