BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    VITROS CA 125 II Calibrator

    Reg #: 3007111389 · FEI: 3007111389 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics
    Registration Number
    3007111389
    FEI Number
    3007111389
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Felindre Meadows
    City
    Pencoed Bridgend
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K221355

    Owner / Operator

    Firm Name
    QuidelOrtho Corp.
    Operator Number
    2024674
    Address
    9975 Summers Ridge Road, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    US Agent

    Business Name
    Ortho-Clinical Diagnostics, Inc.
    Contact Name
    Marlene Hanna
    Address
    100 Indigo Creek Drive
    City
    Rochester
    State
    NY
    ZIP
    14626
    Country
    US
    Email
    [email protected]
    Phone
    585 4534041

    Products

    Device Name Product Code
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK

    Proprietary Names

    VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack

    Establishment Types

    Manufacture Medical Device