{
  "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": [
        "Ezplex SARS-CoV-2 G Kit"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3017485950",
        "fei_number": "3017485950",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SML GENETREE CO. LTD.",
        "address_line_1": "1307-1309, 167 Songpa-daero",
        "address_line_2": "Songpa-gu",
        "city": "Seoul",
        "state_code": "",
        "iso_country_code": "KR",
        "zip_code": "",
        "postal_code": "05855",
        "us_agent": {
          "name": "Sujung Park",
          "business_name": "",
          "bus_phone_area_code": "408",
          "bus_phone_num": "2367345",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "spark@fidealaw.com",
          "address_line_1": "2445 Augustine Drive, Suite 150",
          "address_line_2": "Santa Clara, CA 95054",
          "city": "Santa Clara",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "95054",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SML Genetree Co. Ltd.",
          "owner_operator_number": "10076632",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "1307-1309, 167, Songpa-daero",
            "address_2": "Songpa-gu",
            "city": "Seoul",
            "state_code": "KR-11",
            "state_province": "",
            "iso_country_code": "KR",
            "postal_code": "05855"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "QJR",
          "created_date": "2020-07-24",
          "owner_operator_number": "10076632",
          "exempt": "",
          "openfda": {
            "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "N"
          }
        }
      ]
    }
  ]
}