BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ClearLLab 10C

    DI: 15099590694975 · Model: B90003 · BECKMAN COULTER IRELAND INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ClearLLab 10C
    Primary DI
    15099590694975
    Version / Model
    B90003
    Company Name
    BECKMAN COULTER IRELAND INC.
    Labeler DUNS
    985071975
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-26
    Public Version
    1
    Public Version Date
    2019-04-03
    Public Version Status
    New
    Public Device Record Key
    38ee3bc5-2736-4d72-8add-5be4dfcf886b

    Device Description

    ClearLLab Control Cells abnormal

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PWD Flow Cytometric Test System For Hematopoietic Neoplasms

    GMDN Terms

    Code Name
    56919 Multiple CD cell marker IVD, control

    Identifiers

    Type ID
    Primary 15099590694975

    Premarket Submissions

    Submission Number Supplement Number
    K183592 000