FDA product code OZA: Test, Urea Adult And Pediatric (Breath),
OZA is the FDA product code for test, urea adult and pediatric (breath),. It is a Class III device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. Devices under OZA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Urea Adult And Pediatric (Breath), |
| Device class | Class III |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | PMA |
Recalls for OZA devices
openFDA lists no recalls for product code OZA.
Frequently asked questions
What is FDA product code OZA?
OZA is the FDA product code for test, urea adult and pediatric (breath),. It is a Class III device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is OZA?
Class III, regulation 21 CFR 866.3110. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OZA
- Run a recall and safety report across every OZA manufacturer
- Watch product code OZA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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