BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    C. DIFFICILE TOX-B TEST

    DI: 00857031002264 · Model: T5003 · TECHLAB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    C. DIFFICILE TOX-B TEST
    Primary DI
    00857031002264
    Version / Model
    T5003
    Company Name
    TECHLAB, INC.
    Labeler DUNS
    614218634
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-24
    Public Version
    1
    Public Version Date
    2020-02-03
    Public Version Status
    New
    Public Device Record Key
    cf4aefed-41a7-49ac-8a89-75c5657369e2

    Device Description

    The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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

    Product Codes

    Code Name
    LLH Reagents, Clostridium Difficile Toxin

    GMDN Terms

    Code Name
    63037 Clostridium difficile antigen IVD, kit, cell culture assay

    Identifiers

    Type ID
    Primary 00857031002264