BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632

    DI: 00817302020885 · Model: AU-632 · 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.® APOA RGT. KIT AU-632
    Primary DI
    00817302020885
    Version / Model
    AU-632
    Catalog Number
    AU-632
    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
    15c239d8-5dd9-40ee-8df2-e631fa097c5a

    Device Description

    APO A1 (Apolipoprotein A1) 3 x 200 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
    DER ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    53443 Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 00817302020885

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Kit contains 3 R1 and 3 R2 bottles and 1 package insert
    Total Volume 46 Milliliter
    Total Volume 16 Milliliter

    Storage Conditions

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