Device Category Dossier

CT947 - Human papilloma virus IVDs

Device Category Dossier for CT947 - Human papilloma virus IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Human papillomavirus in vitro diagnostic devices are qualitative multiplex nucleic acid real-time PCR assays that detect and identify the genomic DNA of high-risk human papillomavirus types extracted from clinical specimens. These devices are used as an aid in diagnosing human papillomavirus infections in patients with cervical cytology or positive HPV molecular test results.