PQA

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Product code

PQA

Device name

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Device class

Class 2

21 CFR

21 CFR 866.3975

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

12 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-07-16.

3 summaries are archived here for direct download.