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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Influenza B IgG ELISA Test Kit

    DI: B350GSD0130100 · Model: GSD01-3010 · Gold Standard Diagnostics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Influenza B IgG ELISA Test Kit
    Primary DI
    B350GSD0130100
    Version / Model
    GSD01-3010
    Catalog Number
    GSD01-3010
    Company Name
    Gold Standard Diagnostics Corporation
    Labeler DUNS
    790524891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-07
    Public Version
    1
    Public Version Date
    2022-10-17
    Public Version Status
    New
    Public Device Record Key
    7580a922-0ca2-4294-a469-81cb765cda33

    Device Description

    Gold Standard Diagnostics Influenza B IgG ELISA Test Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    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
    GNW Antisera, Cf, Influenza Virus A, B, C

    GMDN Terms

    Code Name
    49214 Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B350GSD0130100

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius