BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AESKULISA® ANA HEp-2

    DI: 04250289503501 · Model: 30-7115US · Aesku.Diagnostics GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AESKULISA® ANA HEp-2
    Primary DI
    04250289503501
    Version / Model
    30-7115US
    Catalog Number
    30-7115US
    Company Name
    Aesku.Diagnostics GmbH & Co. KG
    Labeler DUNS
    341714388
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-28
    Public Version
    5
    Public Version Date
    2026-04-28
    Public Version Status
    Update
    Public Device Record Key
    4e13136a-5aa2-4165-ba27-2d265c432fee

    Device Description

    AESKULISA® ANA HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against Hep2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

    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
    LKJ Antinuclear Antibody, Antigen, Control

    GMDN Terms

    Code Name
    54809 Multiple antinuclear antibody (ANA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04250289503501

    Premarket Submissions

    Submission Number Supplement Number
    K081104 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius