{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "IDS-iSYS Cuvettes",
        "IDS-iSYS Cartridge Check System (CCS)",
        "IDS-iSYS System Liquid (Syst l)",
        "IDS-iSYS Wash Solution (Wash S)",
        "IDS Immunocleaner",
        "IDS-iSYS Trigger Set",
        "IDS-iSYS D-Sorb Solution"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3007500635",
        "fei_number": "3007500635",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Immunodiagnostic Systems SA",
        "address_line_1": "Rue Ernest Solvay 101",
        "address_line_2": "",
        "city": "Liege      Liege",
        "state_code": "",
        "iso_country_code": "BE",
        "zip_code": "",
        "postal_code": "4000",
        "us_agent": {
          "name": "Faith Du",
          "business_name": "Euroimmun US Inc.",
          "bus_phone_area_code": "800",
          "bus_phone_num": "9132022",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "ra-us@euroimmun.us",
          "address_line_1": "1 Bloomfield Avenue",
          "address_line_2": "Mountain Lakes",
          "city": "Mountain Lakes",
          "state_code": "NJ",
          "iso_country_code": "US",
          "zip_code": "07046",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "IMMUNODIAGNOSTIC SYSTEMS LTD.",
          "owner_operator_number": "8021924",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "10 DIDCOT WAY",
            "address_2": "BOLDON BUSINESS PARK",
            "city": "BOLDON COLLIERY",
            "state_code": "GB-NOTA",
            "state_province": "",
            "iso_country_code": "GB",
            "postal_code": "NE35 9PD"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "JJE",
          "created_date": "2009-12-02",
          "owner_operator_number": "8021924",
          "exempt": "",
          "openfda": {
            "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2160",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}