{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OZZ",
      "openfda": {
        "k_number": [
          "K163626",
          "K181029",
          "K243753",
          "K183223",
          "K173498",
          "K133673",
          "K143206",
          "K152285",
          "K170284"
        ],
        "registration_number": [
          "3003030793",
          "1524213",
          "3002773840",
          "2243471",
          "2023365",
          "1650733",
          "1528450",
          "3010770794",
          "3006198300",
          "3004141078",
          "3006028115",
          "3007799234",
          "3010749841"
        ],
        "fei_number": [
          "3003030793",
          "1524213",
          "1000122536",
          "3002773840",
          "2243471",
          "2023365",
          "3010770794",
          "3006198300",
          "3004141078",
          "3006028115",
          "3007799234",
          "3010749841",
          "3002524000"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Bordetella Pertussis Dna Assay System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.",
      "regulation_number": "866.3980",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}