BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-A (Murine Monoclonal) Gamma-clone

    DI: 10888234001690 · Model: 0410203 · IMMUCOR, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-A (Murine Monoclonal) Gamma-clone
    Primary DI
    10888234001690
    Version / Model
    0410203
    Catalog Number
    0410203
    Company Name
    IMMUCOR, INC.
    Labeler DUNS
    061446282
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8883be14-0222-47d2-9f7f-cc3152dbd01b

    Device Description

    This reagent is used in slide, tube and microplate tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is three (3) vials of reagent.

    Device Characteristics

    Single Use
    Yes
    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
    52532 Anti-A red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Primary 10888234001690

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    1 – 10 Degrees Celsius