{
  "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": "PCG",
      "openfda": {
        "k_number": [
          "K180607",
          "K121046"
        ],
        "registration_number": [
          "2025560",
          "2245285",
          "3002800697",
          "3003834021"
        ],
        "fei_number": [
          "2025560",
          "2245285",
          "3002808039",
          "3002800697"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "21-Hydroxylase Antibody (21-Ohab)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.",
      "regulation_number": "866.5660",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}