BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Gliadin IgG ELISA

    DI: 04048474033717 · Model: EIA-3371 · 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
    Gliadin IgG ELISA
    Primary DI
    04048474033717
    Version / Model
    EIA-3371
    Catalog Number
    EIA-3371
    Company Name
    DRG Instruments Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317134468
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-29
    Public Version
    2
    Public Version Date
    2025-07-14
    Public Version Status
    Update
    Public Device Record Key
    ee44c6f9-094c-4a57-ade6-fee1ccb6cbc1
    Distribution End Date
    2025-07-11

    Device Description

    The DRG Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease

    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
    MST Antibodies, Gliadin

    GMDN Terms

    Code Name
    54947 Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04048474033717

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K990204 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius