BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HbA1c Assay

    DI: 00628063401147 · Model: SK350-60 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HbA1c Assay
    Primary DI
    00628063401147
    Version / Model
    SK350-60
    Catalog Number
    SK350-60
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    2
    Public Version Date
    2020-11-09
    Public Version Status
    Update
    Public Device Record Key
    9ef037f8-f0e6-44fc-86fc-846c79e4cc03

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    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
    PDJ Hemoglobin A1c test system
    LCP ASSAY, GLYCOSYLATED HEMOGLOBIN

    GMDN Terms

    Code Name
    53316 Glycated haemoglobin (HbA1c) IVD, reagent

    Identifiers

    Type ID
    Primary 00628063401147