BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit

    DI: 00817302022308 · Model: AU-204B · 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.® Lipoprotein (a) Assay Kit
    Primary DI
    00817302022308
    Version / Model
    AU-204B
    Catalog Number
    AU-204B
    Company Name
    CAROLINA LIQUID CHEMISTRIES CORPORATION
    Labeler DUNS
    962385787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-07
    Public Version
    2
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    df94dcf4-98c9-4544-9a26-4bc701e8e2fa

    Device Description

    Lp (a) Lipoprotein AU-204B

    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
    DFC LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    53438 Lipoprotein A IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 00817302022308

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K180074 000

    Device Sizes

    Type Value Unit Text
    Total Volume 45 Milliliter
    Total Volume 15 Milliliter
    Device Size Text, specify Kit contains 3 R1 and 3 R2 bottles

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable when stored unopened at 2-8° C until expiration date.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius