{
  "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": "2026-08-03",
    "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": "NUA",
      "openfda": {
        "k_number": [
          "K083845",
          "K163347",
          "K163336",
          "K062028",
          "K063787",
          "K060627",
          "DEN050004",
          "K090901",
          "K083846",
          "K051435",
          "K060543",
          "K083294"
        ],
        "registration_number": [
          "3002777243"
        ],
        "fei_number": [
          "3002777243"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "IM",
      "device_name": "System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene.  It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening.  This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.",
      "regulation_number": "866.5900",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}