Device type

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Product code PQA · Class II · 21 CFR 866.3975 · Microbiology

A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.

FDA classification database