BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616

    DI: 00817302022209 · Model: AU-616 · 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.® HDLD RGT. KIT AU-616
    Primary DI
    00817302022209
    Version / Model
    AU-616
    Catalog Number
    AU-616
    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
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    eee322a4-e7f6-46b5-95f8-e5845ae1baa0

    Device Description

    HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 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
    LBR LDL & VLDL PRECIPITATION, HDL
    LBS LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

    GMDN Terms

    Code Name
    53391 High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817302022209

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 60 Milliliter
    Device Size Text, specify Kit contians 3 R1, 3 R2, 1 cal 3, 1 calibrator package insert and 1 reagent package insert
    Total Volume 3 Milliliter
    Total Volume 20 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Reagent is stable on board a clinical analyzer for 30 days
    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