BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIASTAT ENA Single Well Screen

    DI: 07340058410493 · Model: FSWS200 · Euro-Diagnostica AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIASTAT ENA Single Well Screen
    Primary DI
    07340058410493
    Version / Model
    FSWS200
    Catalog Number
    FSWS200
    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
    3
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    94b2aa89-c030-4f60-9b7c-991238b34ab1

    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

    GMDN Terms

    Code Name
    54823 Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07340058410493