BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Titan Prime Universal AP Polymer Detection Kit with Fast Red

    DI: 00850042030202 · Model: 1 · Lumatas Biosystems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Titan Prime Universal AP Polymer Detection Kit with Fast Red
    Primary DI
    00850042030202
    Version / Model
    1
    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
    df98a04a-14cd-456d-8c5a-3022c0fd4fc3

    Device Description

    A Detection System Kit containing four components. Polymer based detection system used in conjunction with Fast Red chromogen to allow for the visualization of tissue samples.

    Device Characteristics

    Single Use
    No
    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
    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
    NJT Immunohistochemistry Reagents And Kits

    GMDN Terms

    Code Name
    57771 Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary 00850042030202

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius