BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alegria Flash ENA Screen

    DI: 00845533003063 · Model: CL28051 · 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
    Alegria Flash ENA Screen
    Primary DI
    00845533003063
    Version / Model
    CL28051
    Catalog Number
    CL28051
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-19
    Public Version
    1
    Public Version Date
    2026-02-27
    Public Version Status
    New
    Public Device Record Key
    0452e5b7-ceee-47fe-9aea-226c2ba8db04

    Device Description

    The Alegria Flash ENA Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or sm-RNP in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD) Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), Systemic Sclerosis (SSC).

    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
    59748 Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00845533003063

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius