BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent

    DI: 10888234002239 · Model: 10 mL size vial / 5mL fill volume · IMMUCOR, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent
    Primary DI
    10888234002239
    Version / Model
    10 mL size vial / 5mL fill volume
    Catalog Number
    0066430
    Company Name
    IMMUCOR, INC.
    Labeler DUNS
    061446282
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-22
    Public Version
    1
    Public Version Date
    2022-05-02
    Public Version Status
    New
    Public Device Record Key
    e299d34b-edac-4c33-b45c-ff3cc076dba4

    Device Description

    Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    52569 Anti-Fy^a red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Primary 10888234002239