{
  "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": 13
    }
  },
  "results": [
    {
      "proprietary_name": [
        "BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel",
        "BioFire Global Fever Special Pathogens Panel"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3010770794",
        "fei_number": "3010770794",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "BioFire Defense, LLC",
        "address_line_1": "79 W 4500 S Ste 14",
        "address_line_2": "",
        "city": "Salt Lake City",
        "state_code": "UT",
        "iso_country_code": "US",
        "zip_code": "84107",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "BIOMERIEUX SA",
          "owner_operator_number": "8020790",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Chemin De L Orme",
            "address_2": "",
            "city": "Marcy L Etoile",
            "state_code": "FR-69",
            "state_province": "Rhone",
            "iso_country_code": "FR",
            "postal_code": "69280"
          }
        }
      },
      "pma_number": "",
      "k_number": "K213362",
      "products": [
        {
          "product_code": "QVR",
          "created_date": "2023-06-12",
          "owner_operator_number": "8020790",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K213362"
            ],
            "device_name": "Multiplex Nucleic Acid Detection System For Biothreat Agents",
            "medical_specialty_description": "Immunology",
            "regulation_number": "866.4000",
            "device_class": "2"
          }
        },
        {
          "product_code": "PMN",
          "created_date": "2023-06-12",
          "owner_operator_number": "8020790",
          "exempt": "",
          "openfda": {
            "device_name": "Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3920",
            "device_class": "2"
          }
        },
        {
          "product_code": "QMV",
          "created_date": "2023-06-12",
          "owner_operator_number": "8020790",
          "exempt": "",
          "openfda": {
            "device_name": "Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3966",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}