BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Direct Glycohemoglobin (HbA1c) Control Set

    DI: 00657498000892 · Model: 0355-201 · STANBIO LABORATORY, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Direct Glycohemoglobin (HbA1c) Control Set
    Primary DI
    00657498000892
    Version / Model
    0355-201
    Catalog Number
    0355-201
    Company Name
    STANBIO LABORATORY, L.P.
    Labeler DUNS
    045361136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    de3690c0-cf1e-49f4-a6a6-07c942e70b51

    Device Description

    For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    55874 Total haemoglobin (totHb) IVD, control

    Identifiers

    Type ID
    Primary 00657498000892

    Customer Contacts

    Phone
    18005315535
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius