BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trinity Biotech

    DI: 05391516749909 · Model: Premier Buffer A Plus Reagent - 3.8 L · PRIMUS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trinity Biotech
    Primary DI
    05391516749909
    Version / Model
    Premier Buffer A Plus Reagent - 3.8 L
    Catalog Number
    01-03-0055
    Company Name
    PRIMUS CORPORATION
    Labeler DUNS
    790074793
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-12
    Public Version
    2
    Public Version Date
    2024-12-23
    Public Version Status
    Update
    Public Device Record Key
    aee96e66-29f2-4dfe-b7c7-6ea436138872

    Device Description

    Hemoglobin A1c assay, Premier Buffer A Plus Reagent – 3.8L

    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
    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
    53316 Glycated haemoglobin (HbA1c) IVD, reagent

    Identifiers

    Type ID
    Primary 05391516749909