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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R

    DI: 00853931008009 · Model: HLC-723G8R · TOSOH BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R
    Primary DI
    00853931008009
    Version / Model
    HLC-723G8R
    Catalog Number
    021560R
    Company Name
    TOSOH BIOSCIENCE, INC.
    Labeler DUNS
    607696440
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-26
    Public Version
    2
    Public Version Date
    2018-06-08
    Public Version Status
    Update
    Public Device Record Key
    76296d1c-f70d-4b59-a4bd-961586c99054

    Device Description

    Glycated Hemoglobin (HbA1C) Analyzer IVD

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LCP Assay, Glycosylated Hemoglobin

    GMDN Terms

    Code Name
    35968 Glycated haemoglobin (HbA1C) analyser IVD

    Identifiers

    Type ID
    Primary 00853931008009

    Customer Contacts

    Phone
    6143171916
    Email
    [email protected]