{
  "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": 24
    }
  },
  "results": [
    {
      "proprietary_name": [
        "PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131",
        "Custom Immunassay Control Levels 1,2 and 3, IAC100, IAC101, IAC102",
        "Immunoassay Control Level 1, 2 & 3 LIA5142, LIA5143, LIA5144",
        "General Chemistry Control Level 1, 2 and 3",
        "Customised Apolipoprotein Control Level 1 and Level 2, LP052/002/CM. LP053/002/CM",
        "HUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2)",
        "RANDOX HUMAN PRECISION CONTROLS",
        "HUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3)",
        "BOVINE PRECISION MULTI SERA - LEVEL 2 (BOV PREC CONTROL 2)",
        "LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)",
        "BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3)",
        "RANDOX LIQUID CHEMISTRY PREMIUM CONTROLS",
        "LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 3 (LIQ CHEM PREMIUM PLUS 3)",
        "RANDOX LIQUID CHEMISTRY PREMIUM PLUS CONTROLS",
        "LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1)",
        "RANDOX BOVINE PRECISION MULTI SERA",
        "BOVINE PRECISION MULTI SERA - LEVEL 1 (BOV PREC CONTROL 1)",
        "RANDOX PRECISION CHEMISTRY PREMIUM PLUS CONTROLS",
        "LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 2 (LIQ CHEM PREMIUM PLUS 2)",
        "LIQUID CHEMISTRY PREMIUM - LEVEL 3 (LIQ CHEM PREMIUM 3)",
        "RANDOX BOVINE PRECISION CONTROLS",
        "SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)",
        "SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)",
        "SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)",
        "SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +)",
        "SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +)",
        "Randox Liquid Chemistry Premium Plus levels 1,2 and 3",
        "SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)",
        "SERUM INDICES (SERUM INDICES)",
        "SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)",
        "SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)",
        "XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA CONTROL -)",
        "XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)",
        "Custom Cardiac Controls Levels 1, 2 and 3, CQ039, CQ040, CQ041",
        "Apolipoprotein Control Levels 1, 2 and 3"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Repack or Relabel Medical Device",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3014607865",
        "fei_number": "3014607865",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "RANDOX LABORATORIES LIMITED",
        "address_line_1": "30 RANDALSTOWN ROAD",
        "address_line_2": "",
        "city": "ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey",
        "state_code": "",
        "iso_country_code": "GB",
        "zip_code": "",
        "postal_code": "BT41 4FL",
        "us_agent": {
          "name": "John Naizer",
          "business_name": "RANDOX LABORATORIES-US, LTD",
          "bus_phone_area_code": "304",
          "bus_phone_num": "7282890",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "John.Naizer@randox.com",
          "address_line_1": "515 Industrial Boulevard",
          "address_line_2": "",
          "city": "Kearneysville",
          "state_code": "WV",
          "iso_country_code": "US",
          "zip_code": "25430",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "RANDOX LABORATORIES, LTD.",
          "owner_operator_number": "8020890",
          "official_correspondent": {
            "first_name": "Karena",
            "middle_initial": "-",
            "last_name": "Shaw",
            "subaccount_company_name": "",
            "phone_number": "44-28-94422413-x"
          },
          "contact_address": {
            "address_1": "55 DIAMOND RD.",
            "address_2": "--",
            "city": "CRUMLIN, CO.ANTRIM",
            "state_code": "GB-NOTA",
            "state_province": "",
            "iso_country_code": "GB",
            "postal_code": "BT29 4QY"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "OHQ",
          "created_date": "2011-08-03",
          "owner_operator_number": "8020890",
          "exempt": "",
          "openfda": {
            "device_name": "Multi-Analyte Controls Unassayed",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1660",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}