BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hemosure® Accu-Reader®

    DI: 00817763022770 · Model: A100 · W.H.P.M. INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hemosure® Accu-Reader®
    Primary DI
    00817763022770
    Version / Model
    A100
    Company Name
    W.H.P.M. INC.
    Labeler DUNS
    602085672
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-10
    Public Version
    1
    Public Version Date
    2023-05-18
    Public Version Status
    New
    Public Device Record Key
    5793e71a-560d-4408-8bce-b5ceac8abe5b

    Device Description

    Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader® A100 is comprised of Hemosure® Accu-Reader® A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader® A100 Control and Hemosure® Accu-Reader® A100 Calibration Cartridge Kit.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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

    GMDN Terms

    Code Name
    54532 Faecal occult blood IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00817763022770