Device Dossier
Human papilloma virus IVDs
Device Dossier for Human papilloma virus IVDs (CT947 - Human papilloma virus IVDs, Class 3, sponsor Becton Dickinson). ARTG record, intended purpose,…
- GMDN category: CT947 - Human papilloma virus IVDs
- Sponsor: Becton Dickinson
Intended purpose
An amplified DNA test for the qualitative detection of high risk types of human papillomavirus (HPV) using the BD Viper LT and BD COR instrument systems. The BD Onclarity HPV Assay may be used for population based screening of the 14 high risk HPV genotypes including identification of HPV 16 and 18 in liquid-based cytology specimens. Self-collected and physician collected vaginal specimens can be tested with the BD Onclarity HPV Assay for cervical cancer screening.