{
  "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": [
        "IntelliPrep Blood Genomic DNA Extraction Kit",
        "IntelliPrep FFPE DNA Extraction Kit",
        "IntelliPrep FFPE RNA Extraction Kit",
        "IntelliPrep Viral DNA/RNA Extraction Kit",
        "IntelliPrep cfDNA Extraction Kit",
        "IntelliPrep FFPE DNA Plus Extraction Kit",
        "IntelliPrep TRIO 240 Sample Preparation System",
        "IntelliPrep Blood total RNA Extraction Kit"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3009214950",
        "fei_number": "3009214950",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "PLEXBIO CO. LTD.",
        "address_line_1": "6F-1, No.351, Yangguang St., Neihu Dist.",
        "address_line_2": "",
        "city": "Taipei City",
        "state_code": "",
        "iso_country_code": "TW",
        "zip_code": "",
        "postal_code": "114",
        "us_agent": {
          "name": "Li Jiang",
          "business_name": "Hetai, Inc.",
          "bus_phone_area_code": "415",
          "bus_phone_num": "5315271",
          "bus_phone_extn": "",
          "fax_area_code": "415",
          "fax_num": "5315271",
          "email_address": "lee.jiang@hetai.co",
          "address_line_1": "458 Carlton Court",
          "address_line_2": "",
          "city": "South San Francisco",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "94080",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "PlexBio Co. Ltd.",
          "owner_operator_number": "10080753",
          "official_correspondent": {
            "first_name": "Amber",
            "middle_initial": "",
            "last_name": "Chen",
            "subaccount_company_name": "",
            "phone_number": "886-02-26275878-110"
          },
          "contact_address": {
            "address_1": "6F-1, No.351, Yangguang St., Neihu Dist.",
            "address_2": "",
            "city": "Taipei City",
            "state_code": "TW-TPE",
            "state_province": "",
            "iso_country_code": "TW",
            "postal_code": "114"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "JJH",
          "created_date": "2021-11-18",
          "owner_operator_number": "10080753",
          "exempt": "",
          "openfda": {
            "device_name": "Clinical Sample Concentrator",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2310",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}