# C. Difficile Nucleic Acid Amplification Test Assay
> **Product code: OMN** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2660
## Classification
- **FDA Product Code:** OMN
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.2660
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OMN)
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