BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BOND-MAX Processing Module

    DI: 09349458005689 · Model: BOND-MAX · LEICA BIOSYSTEMS MELBOURNE PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BOND-MAX Processing Module
    Primary DI
    09349458005689
    Version / Model
    BOND-MAX
    Catalog Number
    RS49.0051
    Company Name
    LEICA BIOSYSTEMS MELBOURNE PTY LTD
    Labeler DUNS
    753184944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-30
    Public Version
    1
    Public Version Date
    2025-07-08
    Public Version Status
    New
    Public Device Record Key
    a88e5a25-4309-4fe6-9140-5cbacd7f3203

    Device Description

    The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPA Slide Stainer, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 09349458005689