{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 46
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit"
      ],
      "establishment_type": [
        "Repack or Relabel Medical Device",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3007208259",
        "fei_number": "3007208259",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "GOLD STANDARD DIAGNOSTICS, LLC",
        "address_line_1": "2795 2nd St Ste 300",
        "address_line_2": "",
        "city": "Davis",
        "state_code": "CA",
        "iso_country_code": "US",
        "zip_code": "95618",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Gold Standard Diagnostics",
          "owner_operator_number": "10025460",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "2795 2nd Street",
            "address_2": "Suite 300",
            "city": "Davis",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "95618"
          }
        }
      },
      "pma_number": "",
      "k_number": "K993294",
      "products": [
        {
          "product_code": "LKJ",
          "created_date": "2025-02-24",
          "owner_operator_number": "10025460",
          "exempt": "",
          "openfda": {
            "device_name": "Antinuclear Antibody, Antigen, Control",
            "medical_specialty_description": "Immunology",
            "regulation_number": "866.5100",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}