BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FORA

    DI: 00816042015205 · Model: 6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace Voice · FORA CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    FORA
    Primary DI
    00816042015205
    Version / Model
    6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace Voice
    Company Name
    FORA CARE INC.
    Labeler DUNS
    004340807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2025-03-14
    Public Version
    1
    Public Version Date
    2025-03-24
    Public Version Status
    New
    Public Device Record Key
    37d3d625-01fa-40ca-b80b-c5462736ed08

    Device Description

    Total Cholesterol Test Strips

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    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
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

    GMDN Terms

    Code Name
    53362 Total cholesterol lipid IVD, reagent

    Identifiers

    Type ID
    Unit of Use 80816042015201
    Primary 00816042015205