BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE REAGENT KIT 88809

    DI: 00817302020564 · Model: 88809 · 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.® CREATININE REAGENT KIT 88809
    Primary DI
    00817302020564
    Version / Model
    88809
    Catalog Number
    88809
    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
    2023-08-14
    Public Version Status
    Update
    Public Device Record Key
    01f68693-3d8c-4818-b2fc-d36fd319a5b9

    Device Description

    CREA3 (Creatinine) - Modular & CX3 Reagent 3 x 2000 mL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    CGX ALKALINE PICRATE, COLORIMETRY, CREATININE

    GMDN Terms

    Code Name
    53251 Creatinine IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817302020564

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Kit containts 3 R1, 3 R2 bottles and 1 package insert
    Total Volume 400 Milliliter
    Total Volume 1600 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable when stored at 8-30° C until expiration date
    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable on board a clinical analyzer for 30 days when stored at room temperature (8 - 35° C)
    Type
    Storage Environment Temperature
    Temperature Range
    8 – 30 Degrees Celsius