BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alpha2-macroglobulin

    DI: 05415168006873 · Model: 09029524190 · Diagam
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alpha2-macroglobulin
    Primary DI
    05415168006873
    Version / Model
    09029524190
    Catalog Number
    09029524190
    Company Name
    Diagam
    Labeler DUNS
    374384030
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-07
    Public Version
    1
    Public Version Date
    2021-12-15
    Public Version Status
    New
    Public Device Record Key
    349a46f4-4ac9-46e0-84c8-1dba8ceaf106

    Device Description

    In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    Yes
    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53925 Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 05415168006873

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius