BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FREND

    DI: 08809317540917 · Model: COVID-19 total Ab Control LQ · NanoEnTek, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FREND
    Primary DI
    08809317540917
    Version / Model
    COVID-19 total Ab Control LQ
    Catalog Number
    FIC-COALQ
    Company Name
    NanoEnTek, Inc.
    Labeler DUNS
    687910463
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-02
    Public Version
    2
    Public Version Date
    2020-11-04
    Public Version Status
    Update
    Public Device Record Key
    5d6bc5c0-6896-42db-bbfd-103a3ab95a07

    Device Description

    The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.

    Device Characteristics

    Single Use
    No
    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
    QKO Reagent, Coronavirus Serological

    GMDN Terms

    Code Name
    64868 SARS-CoV-2 total antibody IVD, control

    Identifiers

    Type ID
    Primary 08809317540917