{
  "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": 7
    }
  },
  "results": [
    {
      "pma_number": "P170022",
      "supplement_number": "S001",
      "applicant": "Arj Medical, Inc.",
      "street_1": "209 State St. E.",
      "street_2": "",
      "city": "Oldsmar",
      "state": "FL",
      "zip": "34677",
      "zip_ext": "",
      "generic_name": "Test, urea adult and pediatric (breath),",
      "trade_name": "PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer",
      "product_code": "OZA",
      "advisory_committee": "MI",
      "advisory_committee_description": "Microbiology",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2022-05-04",
      "decision_date": "2022-11-30",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer and is indicated for The PyloPlus UBT system. The device, as modified, is 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 of H. pylori infection in adults 18 years old and older. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.",
      "openfda": {
        "device_name": "Test, Urea Adult And Pediatric (Breath),",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3110",
        "device_class": "3",
        "registration_number": [
          "3010837197",
          "3004577174"
        ],
        "fei_number": [
          "3010837197",
          "3004577174"
        ]
      }
    }
  ]
}