BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT AU-208

    DI: 00817302020632 · Model: AU-208 · CAROLINA LIQUID CHEMISTRIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT AU-208
    Primary DI
    00817302020632
    Version / Model
    AU-208
    Catalog Number
    AU-208
    Company Name
    CAROLINA LIQUID CHEMISTRIES CORPORATION
    Labeler DUNS
    962385787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    2bbc04ed-b4fb-4257-9d51-72ad9180ac9d

    Device Description

    GLU (Glucose) 3 x 250 tests

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    CFR HEXOKINASE, GLUCOSE

    GMDN Terms

    Code Name
    53301 Glucose IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817302020632

    Customer Contacts

    Phone
    +1(800)471-7272
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Kit contians 3 R1 bottles and 1 package insert
    Total Volume 60 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable when stored at 2-8° C until expiration date