DeviceClearance

Product code PQA— Microbiology

BD Vaginal Panel

Classification name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device class
Class 2
Regulation
21 CFR 866.3975
Advisory panel
Microbiology
Total cleared
12
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PQA under 21 CFR 866.3975, via openFDA

Market context for product code PQA

FDA has cleared 12 devices under product code PQA between 2016 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQA

Recent clearances under product code PQA

Data sourced from openFDA. This site is unofficial and independent of the FDA.