{
  "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": 8
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Terragene Bionova® Reader Incubators (IC10/20FRLCD, MiniBio)",
        "Terragene Bionova® PCD (PCD224-C, PCD224-2)",
        "Terragene Bionova® SCBI (BT96, BT110, BT224)",
        "Terragene Integron® (IT12, IT26-1YS, IT26-C, IT26-C with extender, PCD26-C)",
        "73170 SEALSURE™ Steam Indicator Tape 18mm",
        "73350 VERISURE™ EO Type 4 Multi-Variable Chemical Indicator Strip",
        "73270 SEALSURE™ VH2O2 Indicator Tape 20mm",
        "73130 BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device",
        "73410 BIOTRACE™ Auto Read Mini Biological Indicator Reader",
        "73210 BIOTRACE™ Auto Read 30 VH2O2 Biological Indicator",
        "73400 BIOTRACE™ Auto Read Pro Biological Indicator Reader",
        "73250 VERISURE™ VH2O2 Type 4 Multi-Variable Chemical Indicator Strip",
        "73150 VERISURE™ Steam Type 5 Migrating Integrator",
        "73100 BIOTRACE™ Auto Read 20 Steam Biological Indicator",
        "73156 VERISURE™ Steam Type 5 Ink Integrator",
        "73260 VERISURE™ VH2O2 Type 1 Chemical Indicator Strip",
        "73300 BIOTRACE™ Auto Read 4H EO Biological Indicator",
        "73165 VERISURE™ Steam Type 4 Multi-Variable Chemical Indicator",
        "73160 VERISURE™ Steam Type 5 Migrating Integrator Process Challenge Device",
        "73155 VERISURE™ Steam Type 5 Migrating Integrator w/ Extender",
        "Terragene Chemdye® (CD16, CD29)",
        "Terragene Cintape® (CT22)"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3013145340",
        "fei_number": "3013145340",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "TERRAGENE SA",
        "address_line_1": "Ruta Nacional No. 9, Km 280",
        "address_line_2": "Parque Industrial  Micropi",
        "city": "Alvear Santa Fe",
        "state_code": "",
        "iso_country_code": "AR",
        "zip_code": "",
        "postal_code": "2130",
        "us_agent": {
          "name": "Maximiliano Catalano",
          "business_name": "Terragene LLC",
          "bus_phone_area_code": "832",
          "bus_phone_num": "9632416",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "asuntos.regulatorios@terragene.com.ar",
          "address_line_1": "25003 Pitkin Rd Ste G400",
          "address_line_2": "",
          "city": "Spring",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "77386",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Terragene SA",
          "owner_operator_number": "10056488",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Ruta Nacional No 9 km 280",
            "address_2": "Parque Industrial Micropi",
            "city": "Alvear",
            "state_code": "AR-S",
            "state_province": "Santa Fe",
            "iso_country_code": "AR",
            "postal_code": "2130"
          }
        }
      },
      "pma_number": "",
      "k_number": "K191021",
      "products": [
        {
          "product_code": "JOJ",
          "created_date": "2019-09-18",
          "owner_operator_number": "10056488",
          "exempt": "",
          "openfda": {
            "device_name": "Indicator, Physical/Chemical Sterilization Process",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.2800",
            "device_class": "2"
          }
        },
        {
          "product_code": "FRC",
          "created_date": "2019-09-18",
          "owner_operator_number": "10056488",
          "exempt": "",
          "openfda": {
            "device_name": "Indicator, Biological Sterilization Process",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.2800",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}