BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BinaxNOW COVID-19/Flu A&B Combo Self Test

    DI: 00811877012054 · Model: 20002051 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BinaxNOW COVID-19/Flu A&B Combo Self Test
    Primary DI
    00811877012054
    Version / Model
    20002051
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-30
    Public Version
    1
    Public Version Date
    2025-02-07
    Public Version Status
    New
    Public Device Record Key
    5856f971-c653-4db3-b69a-19aed7f0b245

    Device Description

    Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    SCA Multi-Analyte Respiratory Virus Antigen Detection Test

    GMDN Terms

    Code Name
    66040 Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

    Identifiers

    Type ID
    Primary 00811877012054