BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HbA1c CONTROL L+ H

    DI: 03661540214905 · Model: HBAC-0049 · VITALSCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HbA1c CONTROL L+ H
    Primary DI
    03661540214905
    Version / Model
    HBAC-0049
    Company Name
    VITALSCIENTIFIC
    Labeler DUNS
    267732378
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2025-01-30
    Public Version Status
    Update
    Public Device Record Key
    e4350539-f5b5-4a2e-89cf-fb79092f50b8

    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

    GMDN Terms

    Code Name
    44435 Glycated haemoglobin (HbA1c) IVD, control

    Identifiers

    Type ID
    Primary 03661540214905