BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Data-Cyte Plus 3%

    DI: 07640137340278 · Model: 11x4 ml · Medion Grifols Diagnostics AG
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Data-Cyte Plus 3%
    Primary DI
    07640137340278
    Version / Model
    11x4 ml
    Catalog Number
    213392
    Company Name
    Medion Grifols Diagnostics AG
    Labeler DUNS
    483287020
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-01-25
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    072253c3-dcab-4fe6-bc84-5ffcfce53cef

    Device Description

    Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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

    GMDN Terms

    Code Name
    52543 Antibody identification panel reagent red blood cell IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 07640137340278