510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OZAClass III

Test, Urea Adult And Pediatric (Breath),

21 CFR 866.3110 / Microbiology
FDA source (opens on fda.gov)

OZA is the FDA product code for Test, Urea Adult And Pediatric (Breath),, a class III device type, regulated under 21 CFR 866.3110. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OZA
Device name
Test, Urea Adult And Pediatric (Breath),
FDA 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.
Regulation
21 CFR 866.3110
Device class
Class III
Review panel
Microbiology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code