BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D

    DI: 00817302020144 · Model: AU-204-D · CAROLINA LIQUID CHEMISTRIES CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D
    Primary DI
    00817302020144
    Version / Model
    AU-204-D
    Catalog Number
    AU-204-D
    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
    8f24364e-2a75-4f20-88c5-22ca39a15c99

    Device Description

    Lp(a) (Lipoprotein (a) 3 x 400 tests

    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
    DFC LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
    JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
    JIT CALIBRATOR, SECONDARY

    GMDN Terms

    Code Name
    55018 LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00817302020144

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 15 Milliliter
    Total Volume 45 Milliliter
    Device Size Text, specify Kit contains 3 R1 bottles, 3 R2 bottles and 1 package insert

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Unopened reagents are stable to expiration date when stored at 2 to 8°C
    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C