BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KETONE SERUM CONTROLS

    DI: 00695684131128 · Model: 13112 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KETONE SERUM CONTROLS
    Primary DI
    00695684131128
    Version / Model
    13112
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-06
    Public Version
    2
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    d7176cf8-0d3d-477f-a825-89579bdfa43d

    Device Description

    Ketone controls for use with ketone tests, 1 Positive and 1 Negative

    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
    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
    30213 Multiple clinical chemistry enzyme IVD, control

    Identifiers

    Type ID
    Primary 00695684131128