BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049

    DI: 00817302022100 · Model: CC049 · CAROLINA LIQUID CHEMISTRIES CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049
    Primary DI
    00817302022100
    Version / Model
    CC049
    Catalog Number
    CC049
    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
    5
    Public Version Date
    2023-08-14
    Public Version Status
    Update
    Public Device Record Key
    a2feada1-e8ac-48f3-9734-d407e374fd47

    Device Description

    CRPhsWR (C-Reactive Protein high sensitivity Wide Range) control

    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
    DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
    JIS CALIBRATOR, PRIMARY

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00817302022100

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K002651 000

    Device Sizes

    Type Value Unit Text
    Total Volume 3 Milliliter
    Device Size Text, specify Kit contains 1 control 1, 1 control 2 and 1 package insert

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Opened vials are stable for 21 days when stored refrigerated at 2 to 8°C.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable when stored at 2-8° C until expiration date
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius