FDA Product Code PQA: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Vaginitis is among the most common reasons women seek gynecological care. FDA product code PQA covers molecular tests for the simultaneous detection and differentiation of vaginitis pathogens and bacterial vaginosis.
These multiplex nucleic acid assays identify Candida species, Trichomonas vaginalis, Gardnerella vaginalis, and other causative organisms from a single vaginal swab, replacing culture and wet mount with a faster and more sensitive molecular result.
PQA devices are Class II medical devices, regulated under 21 CFR 866.3975 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Cepheid, Becton, Dickinson and Company and Hologic, Inc..
List of Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System devices (product code PQA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →