BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AIMTAB KETONE TABLETS

    DI: 00695684131005 · Model: 13100 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    AIMTAB KETONE TABLETS
    Primary DI
    00695684131005
    Version / Model
    13100
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-04-27
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    aa4eb819-4337-4400-98ed-2908efd3cd35

    Device Description

    Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    53341 Ketone (acetoacetate) IVD, reagent

    Identifiers

    Type ID
    Primary 00695684131005
    Unit of Use 00695684131001