BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ALPHA-1-ACID-GLYCOPROTEIN (AGT)

    DI: 05055273200126 · Model: AG2472 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALPHA-1-ACID-GLYCOPROTEIN (AGT)
    Primary DI
    05055273200126
    Version / Model
    AG2472
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-31
    Public Version
    3
    Public Version Date
    2023-03-01
    Public Version Status
    Update
    Public Device Record Key
    f1f53edb-f36b-4b95-b2b9-5704a4c7c069
    Distribution End Date
    2021-07-29

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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
    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 05055273200126

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius