BEUDAMED
    FDA Registration Active 🇫🇷 France

    VITROS CA 19-9 Calibrator

    Reg #: 3000308930 · FEI: 3000308930 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics European Support Center
    Registration Number
    3000308930
    FEI Number
    3000308930
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1500 Boulevard Sebastien Brant, B.P. 30335
    City
    Illkirch, CEDEX Bas-Rhin
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K052889

    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
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    VITROS CA 19-9 Calibrator VITROS CA 19-9 Range Verifiers VITROS CA 19-9 Reagent Pack

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198