BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DG Gel Essential Control

    DI: 07640137341381 · Model: 2x2x6ml · Medion Grifols Diagnostics AG
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DG Gel Essential Control
    Primary DI
    07640137341381
    Version / Model
    2x2x6ml
    Catalog Number
    213288
    Company Name
    Medion Grifols Diagnostics AG
    Labeler DUNS
    483287020
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-23
    Public Version
    1
    Public Version Date
    2019-05-01
    Public Version Status
    New
    Public Device Record Key
    0d72676d-5c4e-4c36-8928-f41d4b4bfea8

    Device Description

    DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for: (i) the determination of the ABO, Rh and K antigens; (ii) the determination of the appropriate ABO blood group antibodies; and (iii) the detection of unexpected antibodies. For use with DG Gel 8 technique. 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
    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

    GMDN Terms

    Code Name
    45310 Multiple immunohaematology test IVD, control

    Identifiers

    Type ID
    Primary 07640137341381