BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Glucose Reagent

    DI: 00812137011985 · Model: 500mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Glucose Reagent
    Primary DI
    00812137011985
    Version / Model
    500mL
    Catalog Number
    501-411
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1aa251a0-6f99-44e6-a954-2847d4f9fb12

    Device Description

    For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders.

    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
    Yes
    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
    CFR Hexokinase, Glucose

    GMDN Terms

    Code Name
    53307 Glucose IVD, reagent

    Identifiers

    Type ID
    Primary 00812137011985

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius