BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CD64 R-PE

    DI: 08719327451083 · Model: IQP-568R · IQ Products B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CD64 R-PE
    Primary DI
    08719327451083
    Version / Model
    IQP-568R
    Catalog Number
    IQP-568R
    Company Name
    IQ Products B.V.
    Labeler DUNS
    490578678
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-26
    Public Version
    1
    Public Version Date
    2023-02-03
    Public Version Status
    New
    Public Device Record Key
    b01b5f1f-304f-4baf-81bd-d2b83461ae6d

    Device Description

    The R-PE conjugated monoclonal antibody CD64 (clone 22) binds to a CD64 epitope distinct from the ligand-binding site and from the clone 32.2 antibody to CD64 epitope. It shows especially high affinity binding to human mononuclear phagocytes and polymorphonuclear leukocytes exposed to IFN-y or G-CSF. Its binding is not blocked in the presence of human IgG or immune complexes. CD64 reacts with the Fc gamma receptor 1 (FcyR1), a glycoprotein with a molecular weight of 72 kDa.The antigen is a high-affinity receptor for IgG and is able to bind human IgG1 and IgG3. The antigen is expressed on macrophages, monocytes, and interferon y (IFN-y) and Granulocyte Colony Stimulating Factor (G-CSF) stimulated neutrophils.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    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

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    57006 CD64 cell marker IVD, antibody

    Identifiers

    Type ID
    Primary 08719327451083

    Customer Contacts

    Phone
    +31505757000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius