OZA

Test, Urea Adult And Pediatric (Breath),

Product code

OZA

Device name

Test, Urea Adult And Pediatric (Breath),

Device class

Class 3

21 CFR

21 CFR 866.3110

Medical specialty

Microbiology

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).