BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anti-nRNP/Sm ELISA (IgG)

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    EUROIMMUN US INC.
    Registration Number
    3007118747
    FEI Number
    3007118747
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Bloomfield Ave
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123261

    Owner / Operator

    Firm Name
    EUROIMMUN US Inc.
    Operator Number
    10025673
    Address
    1 Bloomfield Ave.
    City
    Mountain Lakes
    State
    NJ
    Postal Code
    07046
    Country
    US

    Products

    Device Name Product Code
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Anti-Ribosomal P Antibodies MQA
    Anti-Sm Antibody, Antigen And Control LKP
    Anti-Rnp Antibody, Antigen And Control LKO

    Proprietary Names

    Anti-nRNP/Sm ELISA (IgG) Anti-ribosomal P Proteins ELISA (IgG) Anti-Centromeres ELISA (IgG) Anti-Scl-70 ELISA (IgG) Anti-Jo-1 ELISA (IgG) Anti-Sm ELISA (IgG) Anti-SS-B ELISA (IgG) Anti-SS-A ELISA (IgG)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198