BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FORA

    DI: 00816042013133 · Model: Control Solution (L1) · FORA CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FORA
    Primary DI
    00816042013133
    Version / Model
    Control Solution (L1)
    Company Name
    FORA CARE INC.
    Labeler DUNS
    004340807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-27
    Public Version
    1
    Public Version Date
    2023-07-05
    Public Version Status
    New
    Public Device Record Key
    c8bce379-7052-421a-8503-28df3eae1a30

    Device Description

    For Ketone test

    Device Characteristics

    Single Use
    No
    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
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    53340 Ketone (acetoacetate) IVD, control

    Identifiers

    Type ID
    Primary 00816042013133