BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)

    DI: 00845533001960 · Model: FA9601-1010 · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
    Primary DI
    00845533001960
    Version / Model
    FA9601-1010
    Catalog Number
    FA9601-1010
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-12
    Public Version
    1
    Public Version Date
    2025-05-20
    Public Version Status
    New
    Public Device Record Key
    2460fb07-a25f-4979-882c-c881ebeab286

    Device Description

    The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine®. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFine® must be confirmed by a trained operator.

    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
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
    PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

    GMDN Terms

    Code Name
    55061 Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00845533001960

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius