BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UASure II Blood Uric Acid Monitoring System

    DI: 00886338000031 · Model: S95046 · APEX BIOTECHNOLOGY CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UASure II Blood Uric Acid Monitoring System
    Primary DI
    00886338000031
    Version / Model
    S95046
    Catalog Number
    S95046
    Company Name
    APEX BIOTECHNOLOGY CORP.
    Labeler DUNS
    657608092
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-27
    Public Version
    1
    Public Version Date
    2022-01-04
    Public Version Status
    New
    Public Device Record Key
    5fe440e6-f316-4a53-9054-9054c3c1946d

    Device Description

    Complete Kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LFQ Acid, Uric, Acid Reduction Of Ferric Ion

    GMDN Terms

    Code Name
    53586 Uric acid IVD, reagent
    62221 Uric acid monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00886338000031