# Test, Urea Adult And Pediatric (Breath),
> **Product code: OZA** · Class III — High Risk (PMA approval required, life-sustaining) · Microbiology · 21 CFR 866.3110
## Classification
- **FDA Product Code:** OZA
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 866.3110
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OZA)
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