{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "STARMag 96x4 Universal Cartridge Kit",
        "Seegene STARlet",
        "STARMag 96x4 Universal Plus Cartridge Kit",
        "STARMag 96 X 4 Viral DNA/RNA 200 C Kit",
        "Seegene NIMBUS",
        "STARMag M96 Kit",
        "STARprep™ EZ Buffer"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3008937712",
        "fei_number": "3008937712",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "Seegene Inc.",
        "address_line_1": "Taewon Building",
        "address_line_2": "91, Ogeum-ro",
        "city": "Songpa-gu Seoul",
        "state_code": "",
        "iso_country_code": "KR",
        "zip_code": "",
        "postal_code": "05548",
        "us_agent": {
          "name": "Jun Byum Kim",
          "business_name": "Seegene USA, Inc.",
          "bus_phone_area_code": "800",
          "bus_phone_num": "7252167",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "jbkim@seegene.com",
          "address_line_1": "141 Innovation Dr",
          "address_line_2": "",
          "city": "Irvine",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92617",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Seegene Inc.",
          "owner_operator_number": "10060570",
          "official_correspondent": {
            "first_name": "Hwalee",
            "middle_initial": "",
            "last_name": "Ryu",
            "subaccount_company_name": "",
            "phone_number": "82-2-22405505-x"
          },
          "contact_address": {
            "address_1": "Taewon Building",
            "address_2": "91, Ogeum-Ro",
            "city": "Songpa-gu",
            "state_code": "KR-11",
            "state_province": "Seoul",
            "iso_country_code": "KR",
            "postal_code": "05548"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "JJH",
          "created_date": "2019-05-28",
          "owner_operator_number": "10060570",
          "exempt": "",
          "openfda": {
            "device_name": "Clinical Sample Concentrator",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2310",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}