BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Glomerular Basement Membrane (Primate Kidney)

    DI: 00845533002028 · Model: 5648L · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Glomerular Basement Membrane (Primate Kidney)
    Primary DI
    00845533002028
    Version / Model
    5648L
    Catalog Number
    5648L
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-17
    Public Version
    1
    Public Version Date
    2025-10-27
    Public Version Status
    New
    Public Device Record Key
    b39432a1-bb89-4058-a7a6-378cc25764a3

    Device Description

    Demonstration of Glomerular Basement Membrane antibodies (GBM), by immunofluorescent methods may enable serologic assessment and possible detection of kidney disease. The presence of a histologically defined circulating antibody to the glomerular basement membrane can aid in the patient diagnosis and possible diagnosis in Goodpasture's Syndrome. A linear fluorescence along the Glomerular Basement Membrane can be observed in most Goodpasture's patients.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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

    Product Codes

    Code Name
    MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

    GMDN Terms

    Code Name
    54951 Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00845533002028

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius