# Trichomonas Vaginalis Nucleic Acid Amplification Test System
> **Product code: OUY** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.3860
## Classification
- **FDA Product Code:** OUY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3860
- **Review panel:** MI
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 14
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OUY)
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