# Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
> **Product code: QEP** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3393
## Classification
- **FDA Product Code:** QEP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3393
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.

## Market data
- **Cleared 510(k) submissions:** 21
- **Registered establishments:** 23
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QEP)
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