{
  "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": 58
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Alinity c Proteins Calibrators"
      ],
      "establishment_type": [
        "Repack or Relabel Medical Device",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "9610746",
        "fei_number": "3002806557",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "BIOKIT S.A.",
        "address_line_1": "AV. CAN MONTCAU 7",
        "address_line_2": "",
        "city": "LLISSA D AMUNT Barcelona",
        "state_code": "",
        "iso_country_code": "ES",
        "zip_code": "",
        "postal_code": "08186",
        "us_agent": {
          "name": "Carol Marble",
          "business_name": "",
          "bus_phone_area_code": "800",
          "bus_phone_num": "9559525",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "cmarble@werfen.com",
          "address_line_1": "Hartwell Road 180",
          "address_line_2": "",
          "city": "Bedford",
          "state_code": "MA",
          "iso_country_code": "US",
          "zip_code": "01730",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "BIOKIT S.A.",
          "owner_operator_number": "8030752",
          "official_correspondent": {
            "first_name": "ANGELS",
            "middle_initial": "-",
            "last_name": "ROMA",
            "subaccount_company_name": "",
            "phone_number": "34-93-8609000-x"
          },
          "contact_address": {
            "address_1": "AV CAN MONTCAU, 7",
            "address_2": "--",
            "city": "LLISSA D'AMUNT, BARCELONA",
            "state_code": "ES-B",
            "state_province": "",
            "iso_country_code": "ES",
            "postal_code": "08186"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "JIX",
          "created_date": "2018-12-05",
          "owner_operator_number": "8030752",
          "exempt": "",
          "openfda": {
            "device_name": "Calibrator, Multi-Analyte Mixture",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1150",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}