BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENA Screen (entractable nuclear antigen) ELISA

    DI: 04048474027792 · Model: EIA-2779 · DRG Instruments Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ENA Screen (entractable nuclear antigen) ELISA
    Primary DI
    04048474027792
    Version / Model
    EIA-2779
    Catalog Number
    EIA-2779
    Company Name
    DRG Instruments Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317134468
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-29
    Public Version
    1
    Public Version Date
    2023-09-06
    Public Version Status
    New
    Public Device Record Key
    20ce271f-3c71-4a97-b012-4ed374bda164

    Device Description

    The DRG ENA Screen IgG ELISA Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

    GMDN Terms

    Code Name
    54828 Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04048474027792

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K941014 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius