BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BOND-PRIME

    DI: 09349458005436 · Model: BOND-PRIME ARC REFRESH KIT · 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-PRIME
    Primary DI
    09349458005436
    Version / Model
    BOND-PRIME ARC REFRESH KIT
    Catalog Number
    91.1592
    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
    2021-11-12
    Public Version
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    46db7df8-1849-4599-b4a2-a9b5140bcf23

    Device Description

    The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining platform. The kit contains two items that must be periodically replaced to maintain staining quality: a set of BOND-PRIME Covertiles and a BOND-PRIME Mixing Well Plate.

    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
    No
    Has Lot/Batch Number
    Yes
    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 09349458005436