BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300

    DI: 00817302020076 · Model: AU-300 · 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.® HbA1c RGT. KIT AU-300
    Primary DI
    00817302020076
    Version / Model
    AU-300
    Catalog Number
    AU-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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    22d2c68d-8419-4bd6-8919-b1b9197287b5

    Device Description

    HbA1c (Hemoglobin A1c Direct) 1 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
    LCP ASSAY, GLYCOSYLATED HEMOGLOBIN

    GMDN Terms

    Code Name
    53316 Glycated haemoglobin (HbA1c) IVD, reagent

    Identifiers

    Type ID
    Primary 00817302020076

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Total Volume 30 Milliliter
    Total Volume 10 Milliliter
    Total Volume 15 Milliliter
    Device Size Text, specify Kit contains 1 R1, 1 R2, 1 R1B, 2 Lysis Buffer (B1), and 1 package insert
    Total Volume 23 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    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
    Type
    Special Storage Condition, Specify
    Special Conditions
    Unopened reagents are stable to expiration date with stored at 2 to 8°C