BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EUROPLUS Granulocyte Mosaic 32 EUROPattern

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    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
    K172582

    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
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ

    Proprietary Names

    EUROPLUS Granulocyte Mosaic 32 EUROPattern EUROPLUS Granulocyte Mosaic 22 EUROPattern EUROPLUS Granulocyte Mosaic 25 EUROPattern IFA: Granulocyte Mosaic 13 EUROPattern IFA: Granulocyte Mosaic 2 EUROPattern EUROPattern Classifier

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198