# Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
> **Product code: PQA** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3975
## Classification
- **FDA Product Code:** PQA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3975
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 11
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PQA)
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