BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITROS Isoenzyme PVs

    Reg #: 1319809 · FEI: 1000305840 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Registration Number
    1319809
    FEI Number
    1000305840
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    513 Technology Blvd.
    City
    ROCHESTER
    State
    NY
    ZIP
    14626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K861387

    Owner / Operator

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

    Products

    Device Name Product Code
    Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS

    Proprietary Names

    VITROS Isoenzyme PVs VITROS Calibrator Kit 6 VITROS CK Slides VITROS CKMB Slides

    Establishment Types

    Manufacture Medical Device