BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BinaxNOW Influenza A & B Card 2 Control Swab Kit

    DI: 10811877010989 · Model: 575-080 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BinaxNOW Influenza A & B Card 2 Control Swab Kit
    Primary DI
    10811877010989
    Version / Model
    575-080
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-15
    Public Version
    2
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    02221651-2d20-438b-ab3a-33fee59a0952

    Device Description

    Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.

    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
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

    GMDN Terms

    Code Name
    49121 Influenza A/B virus antigen IVD, control

    Identifiers

    Type ID
    Primary 10811877010989