BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access CEA Calibrators

    DI: 15099590624835 · Model: 33205 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Access CEA Calibrators
    Primary DI
    15099590624835
    Version / Model
    33205
    Catalog Number
    33205
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    3
    Public Version Date
    2023-07-26
    Public Version Status
    Update
    Public Device Record Key
    0f22491a-b49d-4020-9cac-20181c3f2a97

    Device Description

    The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DHX System, Test, Carcinoembryonic Antigen

    GMDN Terms

    Code Name
    54615 Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 15099590624835

    Premarket Submissions

    Submission Number Supplement Number
    K031270 000