{
  "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": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "LumiraDx Instrument V5E (EN,US) EUA",
        "LumiraDx SARS-CoV-2 Ag Control (2pk)EUA",
        "LumiraDx SARS-CoV-2 Ag Test",
        "LumiraDx SARS-CoV-2 Ag Quality Controls",
        "LMDx Instrument V5E (EN,US) EUA,Serviced",
        "LumiraDx SARS-CoV-2 Ag (48T)EUA ,EN-US"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3039322300",
        "fei_number": "3039322300",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Roche Lumira Dx Bathgate",
        "address_line_1": "39 Inchmuir Road",
        "address_line_2": "Whitehill Industrial Estate",
        "city": "Bathgate Scotland",
        "state_code": "",
        "iso_country_code": "GB",
        "zip_code": "",
        "postal_code": "EH48 2EP",
        "us_agent": {
          "name": "Brian Frazier",
          "business_name": "ROCHE DIAGNOSTICS OPERATIONS INC.",
          "bus_phone_area_code": "317",
          "bus_phone_num": "3194485",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "brian.frazier@roche.com",
          "address_line_1": "9115 Hague Rd",
          "address_line_2": "",
          "city": "Indianapolis",
          "state_code": "IN",
          "iso_country_code": "US",
          "zip_code": "46256",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Roche Diagnostics Operations Inc.",
          "owner_operator_number": "9039767",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "9115 Hague Road",
            "address_2": "",
            "city": "Indianapolis",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46250"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "QKP",
          "created_date": "2020-12-07",
          "owner_operator_number": "9039767",
          "exempt": "",
          "openfda": {
            "device_name": "Coronavirus Antigen Detection Test System.",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "N"
          }
        }
      ]
    }
  ]
}