{
  "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": 10
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Colli-Pee Dx Urine Collection Kit"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3004142665",
        "fei_number": "3004142665",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ORASURE TECHNOLOGIES INC.",
        "address_line_1": "220 EAST FIRST STREET",
        "address_line_2": "",
        "city": "BETHLEHEM",
        "state_code": "PA",
        "iso_country_code": "US",
        "zip_code": "18015",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "ORASURE TECHNOLOGIES, INC.",
          "owner_operator_number": "9000083",
          "official_correspondent": {
            "first_name": "Tiffany",
            "middle_initial": "A",
            "last_name": "Miller",
            "subaccount_company_name": "",
            "phone_number": "x-610-8821820-1659"
          },
          "contact_address": {
            "address_1": "220 EAST FIRST STREET",
            "address_2": "--",
            "city": "Bethlehem",
            "state_code": "PA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "18015"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "SIH",
          "created_date": "2026-07-20",
          "owner_operator_number": "9000083",
          "exempt": "",
          "openfda": {
            "device_name": "Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.2920",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}