{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "OZA",
      "openfda": {
        "pma_number": [
          "P100025",
          "P170022"
        ],
        "registration_number": [
          "3010837197",
          "3004577174"
        ],
        "fei_number": [
          "3010837197",
          "3004577174"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Test, Urea Adult And Pediatric (Breath),",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "3",
      "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_number": "866.3110",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}