BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-West Nile Virus ELISA (IgM)

    DI: 04049016028185 · Model: EI 2662-9601 M · EUROIMMUN Medizinische Labordiagnostika AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-West Nile Virus ELISA (IgM)
    Primary DI
    04049016028185
    Version / Model
    EI 2662-9601 M
    Company Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Labeler DUNS
    322209263
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5360f081-cb39-4a65-91d2-3cec2b02725c

    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
    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
    NOP Elisa, Antibody, West Nile Virus

    GMDN Terms

    Code Name
    49049 West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04049016028185

    Premarket Submissions

    Submission Number Supplement Number
    K153308 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius