Product code OZA

Device name

Test, Urea Adult And Pediatric (Breath),

Medical specialty

Microbiology

Device class

3

Regulation number

866.3110

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset