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    FDA UDI In Commercial Distribution 🇺🇸 United States

    THE EDGE Blood Lactate Test Strip (non-sterile)

    DI: 04713648766547 · Model: The EDGE test strip · APEX BIOTECHNOLOGY CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    THE EDGE Blood Lactate Test Strip (non-sterile)
    Primary DI
    04713648766547
    Version / Model
    The EDGE test strip
    Company Name
    APEX BIOTECHNOLOGY CORP.
    Labeler DUNS
    657608092
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-18
    Public Version
    1
    Public Version Date
    2021-01-26
    Public Version Status
    New
    Public Device Record Key
    ff5cde81-d564-4e35-964e-28ea04ba014a

    Device Description

    25s

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    KHP Acid, Lactic, Enzymatic Method

    GMDN Terms

    Code Name
    35885 Lactate monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 04713648766547