# Herpes Simplex Virus Nucleic Acid Amplification Assay
> **Product code: OQO** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3305
## Classification
- **FDA Product Code:** OQO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3305
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

## Market data
- **Cleared 510(k) submissions:** 12
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OQO)
---
*AI Analytics · CC0 1.0*