BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: 00304040019771 · Model: 1126219 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Henry Schein
    Primary DI
    00304040019771
    Version / Model
    1126219
    Catalog Number
    1126219
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    5e450dca-df9d-49f7-97ea-1410b9d9c414

    Device Description

    Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    GNX ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

    GMDN Terms

    Code Name
    49119 Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Package 10304040019778
    Primary 00304040019771

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    No