BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-Cw (Monoclonal) Gamma-clone

    DI: 10888234002376 · Model: 0004819 · IMMUCOR, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-Cw (Monoclonal) Gamma-clone
    Primary DI
    10888234002376
    Version / Model
    0004819
    Catalog Number
    0004819
    Company Name
    IMMUCOR, INC.
    Labeler DUNS
    061446282
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-06
    Public Version
    1
    Public Version Date
    2019-05-14
    Public Version Status
    New
    Public Device Record Key
    06dfe6ab-21a1-4140-b8e6-5cb4590a8938

    Device Description

    Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Cw (RH8) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    52548 Anti-C^w red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Primary 10888234002376

    Customer Contacts

    Phone
    1-855-466-8267
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    1 – 10 Degrees Celsius