BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Glucose Reagent

    DI: 00811403011131 · Model: BK-443355D · Diamond Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Glucose Reagent
    Primary DI
    00811403011131
    Version / Model
    BK-443355D
    Company Name
    Diamond Diagnostics Inc.
    Labeler DUNS
    947514303
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-05
    Public Version
    1
    Public Version Date
    2023-06-13
    Public Version Status
    New
    Public Device Record Key
    15a3dd87-a969-402f-96bd-12865e30476f

    Device Description

    For the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid.

    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
    No
    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
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00811403011131