{
  "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": 19
    }
  },
  "results": [
    {
      "proprietary_name": [
        "NXTAG Respiratory Pathogen Panel"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3002777243",
        "fei_number": "3002777243",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "LUMINEX MOLECULAR DIAGNOSTICS, INC.",
        "address_line_1": "439 UNIVERSITY AVE.",
        "address_line_2": "",
        "city": "TORONTO Ontario",
        "state_code": "",
        "iso_country_code": "CA",
        "zip_code": "",
        "postal_code": "M5G 1Y8",
        "us_agent": {
          "name": "Mari Meyer",
          "business_name": "LUMINEX CORP.",
          "bus_phone_area_code": "715",
          "bus_phone_num": "4107149",
          "bus_phone_extn": "0",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "mari.meyer@diasorin.com",
          "address_line_1": "12212 TECHNOLOGY BLVD.",
          "address_line_2": "",
          "city": "AUSTIN",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "78727",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Luminex Corporation",
          "owner_operator_number": "9032042",
          "official_correspondent": {
            "first_name": "Mari",
            "middle_initial": "",
            "last_name": "Meyer",
            "subaccount_company_name": "",
            "phone_number": "x-715-4107149-x"
          },
          "contact_address": {
            "address_1": "12212 Technology Blvd.",
            "address_2": "",
            "city": "Austin",
            "state_code": "TX",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "78727"
          }
        }
      },
      "pma_number": "",
      "k_number": "K242613",
      "products": [
        {
          "product_code": "OCC",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Respiratory Virus Panel Nucleic Acid Assay System",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "OOU",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Parainfluenza Multiplex Nucleic Acid Assay",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "OTG",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Non-Sars Coronavirus Multiplex Nucleic Acid Assay",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "NXD",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3332",
            "device_class": "2"
          }
        },
        {
          "product_code": "OZY",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Chlamydophila Pneumoniae Dna Assay System",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "OEM",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Human Metapneumovirus (Hmpv) Rna Assay System",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "OOI",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Real Time Nucleic Acid Amplification System",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2570",
            "device_class": "2"
          }
        },
        {
          "product_code": "OZX",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Mycoplasma Pneumoniae Dna Assay System",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        },
        {
          "product_code": "OEP",
          "created_date": "2024-11-26",
          "owner_operator_number": "9032042",
          "exempt": "",
          "openfda": {
            "device_name": "Influenza A Virus Subtype Differentiation Nucleic Acid Assay",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3980",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}