BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SYNCHRON CX® TOTAL PROTEIN REAGENT KIT 88816

    DI: 00817302020762 · Model: 88816 · CAROLINA LIQUID CHEMISTRIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SYNCHRON CX® TOTAL PROTEIN REAGENT KIT 88816
    Primary DI
    00817302020762
    Version / Model
    88816
    Catalog Number
    88816
    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
    af19a303-8a28-439d-a3f9-a075ba2423df

    Device Description

    TP (Total Protein) - CX3 Reagent 4 X 1000 Ml

    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
    CEK BIURET (COLORIMETRIC), TOTAL PROTEIN

    GMDN Terms

    Code Name
    53989 Total protein IVD, reagent

    Identifiers

    Type ID
    Primary 00817302020762

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 1000 Milliliter
    Device Size Text, specify Kit contains 4 reagent bottles and 1 package insert

    Storage Conditions

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