OZA — Test, Urea Adult And Pediatric (Breath), Class III
FDA product code OZA covers "Test, Urea Adult And Pediatric (Breath),", a Class III medical device regulated under 21 CFR 866.3110. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- OZA
- Device Class
- Class III
- Regulation Number
- 866.3110
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.