BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIASTAT anti-B2-Glycoprotein-1 IgM

    DI: 07340058410158 · Model: FBGP100 · Euro-Diagnostica AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIASTAT anti-B2-Glycoprotein-1 IgM
    Primary DI
    07340058410158
    Version / Model
    FBGP100
    Catalog Number
    FBGP100
    Company Name
    Euro-Diagnostica AB
    Labeler DUNS
    559894501
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    bede1a7d-c0a9-437d-a96f-819224bbb1d2

    Device Characteristics

    Single Use
    No
    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
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

    GMDN Terms

    Code Name
    54874 Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07340058410158