BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ID NOW Influenza A & B Control Swab Kit

    DI: 10811877010439 · Model: 425-080 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ID NOW Influenza A & B Control Swab Kit
    Primary DI
    10811877010439
    Version / Model
    425-080
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-29
    Public Version
    2
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    fafdb009-bcdf-41b2-91c5-6e1abb519e7c
    Distribution End Date
    2018-10-29

    Device Description

    Control Swabs intended for use only with the ID NOW Influenza A & B product.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCC Respiratory Virus Panel Nucleic Acid Assay System
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

    GMDN Terms

    Code Name
    47279 Influenza A/B virus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 10811877010439

    Premarket Submissions

    Submission Number Supplement Number
    K171792 000