BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201-300

    DI: 00817302022278 · Model: AU-201-300 · 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 RGT. KIT AU-201-300
    Primary DI
    00817302022278
    Version / Model
    AU-201-300
    Catalog Number
    AU-201-300
    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
    4
    Public Version Date
    2023-08-14
    Public Version Status
    Update
    Public Device Record Key
    6b651082-886b-48ae-9318-45e73f9d8de0

    Device Description

    HCY (Homocysteine) w/ cal 1 x 300 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
    JIT CALIBRATOR, SECONDARY
    LPS URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

    GMDN Terms

    Code Name
    53747 Homocysteine IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817302022278

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 3 Milliliter
    Total Volume 9 Milliliter
    Device Size Text, specify Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
    Total Volume 50 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