BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mouse Kidney/Stomach/Liver Tissue

    DI: 00845533001939 · Model: FA3403 · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Mouse Kidney/Stomach/Liver Tissue
    Primary DI
    00845533001939
    Version / Model
    FA3403
    Catalog Number
    FA3403
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-19
    Public Version
    1
    Public Version Date
    2024-12-27
    Public Version Status
    New
    Public Device Record Key
    4dd99526-dc24-4065-b560-8ee33d0fcdc5

    Device Description

    The Mouse Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders and is for In Vitro diagnostic use.

    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

    GMDN Terms

    Code Name
    54851 Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00845533001939

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius