BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMAGE

    DI: 15099590224066 · Model: 447780 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMMAGE
    Primary DI
    15099590224066
    Version / Model
    447780
    Catalog Number
    447780
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2243c24d-c316-42a6-be5a-aa4e71773072

    Device Description

    IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53606 Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 15099590224066