BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052

    DI: 00817302020106 · Model: CC052 · 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.® HCY LEVEL 2 CONTROL KIT PART# CC052
    Primary DI
    00817302020106
    Version / Model
    CC052
    Catalog Number
    CC052
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b3ad2757-83ab-4516-beb0-d8d7aeae82eb

    Device Description

    HCY (Homocysteine) Level 2 control 6 x 5 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
    JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
    LPS URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

    GMDN Terms

    Code Name
    53750 Homocysteine IVD, control

    Identifiers

    Type ID
    Primary 00817302020106

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 5 Milliliter
    Device Size Text, specify Kit contains 6 control bottles and 1 package insert

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Controls are stable if refrigerated (2 to 8 °) until the date of expiration
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius