BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-Cell Select®

    DI: 05051716000186 · Model: TSK.910 · Oxford Immunotec, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-Cell Select®
    Primary DI
    05051716000186
    Version / Model
    TSK.910
    Catalog Number
    TSK.910US
    Company Name
    Oxford Immunotec, Inc.
    Labeler DUNS
    009744265
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-07
    Public Version
    1
    Public Version Date
    2023-02-15
    Public Version Status
    New
    Public Device Record Key
    fecc2d1c-c4bc-4942-af2e-da8de5ae5be7

    Device Description

    The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.

    Device Characteristics

    Single Use
    Yes
    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
    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
    OJN Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    GMDN Terms

    Code Name
    56610 T lymphocyte magnetic separation reagent IVD

    Identifiers

    Type ID
    Primary 05051716000186

    Premarket Submissions

    Submission Number Supplement Number
    P070006 015