BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Men's Rapid Fertility Test

    DI: 00860001286533 · Model: TQK-0-1 · MEDTOX DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Men's Rapid Fertility Test
    Primary DI
    00860001286533
    Version / Model
    TQK-0-1
    Company Name
    MEDTOX DIAGNOSTICS, INC.
    Labeler DUNS
    118569262
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-26
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    d106a9aa-84fd-4464-a5cb-e53da07b8d7f

    Device Description

    Men's Rapid Fertility Test, QC Kit

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    POV Semen Analysis Device

    GMDN Terms

    Code Name
    61072 Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing

    Identifiers

    Type ID
    Primary 00860001286533