{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 153
    }
  },
  "results": [
    {
      "proprietary_name": [
        "VITROS OP Reagent"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "2250051",
        "fei_number": "2250051",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ORTHO-CLINICAL DIAGNOSTICS, INC.",
        "address_line_1": "1001 US Highway 202",
        "address_line_2": "",
        "city": "RARITAN",
        "state_code": "NJ",
        "iso_country_code": "US",
        "zip_code": "08869",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "QuidelOrtho Corporation",
          "owner_operator_number": "2024674",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "9975 Summers Ridge Road",
            "address_2": "",
            "city": "San Diego",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92121"
          }
        }
      },
      "pma_number": "",
      "k_number": "K062460",
      "products": [
        {
          "product_code": "DIF",
          "created_date": "2022-12-19",
          "owner_operator_number": "2024674",
          "exempt": "",
          "openfda": {
            "device_name": "Drug Mixture Control Materials",
            "medical_specialty_description": "Clinical Toxicology",
            "regulation_number": "862.3280",
            "device_class": "1"
          }
        },
        {
          "product_code": "DJG",
          "created_date": "2022-12-19",
          "owner_operator_number": "2024674",
          "exempt": "",
          "openfda": {
            "device_name": "Enzyme Immunoassay, Opiates",
            "medical_specialty_description": "Clinical Toxicology",
            "regulation_number": "862.3650",
            "device_class": "2"
          }
        },
        {
          "product_code": "DKB",
          "created_date": "2022-12-19",
          "owner_operator_number": "2024674",
          "exempt": "",
          "openfda": {
            "device_name": "Calibrators, Drug Mixture",
            "medical_specialty_description": "Clinical Toxicology",
            "regulation_number": "862.3200",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}