BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lumatas Automated Slide Stainer

    DI: 00850042030004 · Model: Titan · Lumatas Biosystems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lumatas Automated Slide Stainer
    Primary DI
    00850042030004
    Version / Model
    Titan
    Company Name
    Lumatas Biosystems, Inc.
    Labeler DUNS
    080169635
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-25
    Public Version
    1
    Public Version Date
    2023-11-02
    Public Version Status
    New
    Public Device Record Key
    bd15ae0c-b633-43db-86e0-fd626e72b9af

    Device Description

    This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of immuno-reagents (antibodies) to tissue sections.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    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 00850042030004

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    25 – 40 Degrees Celsius