BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioHermes A1cChek Pro Glycohemoglobin Analyzer

    DI: 06935784400026 · Model: A1C EZ Auto 4 W · Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioHermes A1cChek Pro Glycohemoglobin Analyzer
    Primary DI
    06935784400026
    Version / Model
    A1C EZ Auto 4 W
    Catalog Number
    A1C-M31
    Company Name
    Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
    Labeler DUNS
    528192913
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-25
    Public Version
    1
    Public Version Date
    2021-06-02
    Public Version Status
    New
    Public Device Record Key
    213076e3-fa8b-43a4-822d-4bed37d85b9f

    Device Description

    A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    62206 Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

    Identifiers

    Type ID
    Primary 06935784400026