BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IOTest CD8-PC7 (IVD not sold in the US or Canada)

    DI: 15099590391522 · Model: 737661 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IOTest CD8-PC7 (IVD not sold in the US or Canada)
    Primary DI
    15099590391522
    Version / Model
    737661
    Catalog Number
    737661
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    e7597147-22fd-4e8f-8d33-70dadbd05bd1

    Device Description

    IOTest CD8-PC7

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    GKZ Counter, Differential Cell

    GMDN Terms

    Code Name
    56917 Multiple CD cell marker IVD, antibody

    Identifiers

    Type ID
    Primary 15099590391522