BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LABScan™ 100 Systems

    DI: 00812117015699 · Model: N/A · ONE LAMBDA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LABScan™ 100 Systems
    Primary DI
    00812117015699
    Version / Model
    N/A
    Catalog Number
    LABSCNXS2
    Company Name
    ONE LAMBDA, INC.
    Labeler DUNS
    118289289
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    ec196a1d-3493-406e-bee5-f1755abd49a3

    Device Description

    A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and when used with One Lambda’s LABType and LABScreen family of products, the system allows the user to make assignments of HLA antibodies as well as HLA typing with the analysis support of HLA Fusion.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NSU Instrumentation For Clinical Multiplex Test Systems

    GMDN Terms

    Code Name
    56398 HLA class I & II antigen tissue typing IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 00812117015699