{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NUM",
      "openfda": {
        "k_number": [
          "K050662"
        ],
        "registration_number": [
          "3003268355",
          "2026994",
          "3007361513",
          "3012348571",
          "3007118747"
        ],
        "fei_number": [
          "3003268355",
          "2026994",
          "3007361513",
          "3012348571",
          "3007118747"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Autoantibodies, Nuclear Body Protein, Sp100",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.",
      "regulation_number": "866.5090",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}