BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    EliA RNP70 Immunoassay

    Reg #: 9610566 · FEI: 3002807876 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PHADIA AB
    Registration Number
    9610566
    FEI Number
    3002807876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RAPSGATAN 7P
    City
    UPPSALA
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K182353

    Owner / Operator

    Firm Name
    PHADIA AB
    Operator Number
    9004441
    Address
    Rapsgatan 7P, P.O. Box 6460
    City
    UPPSALA
    State
    SE-C
    Postal Code
    75137
    Country
    SE

    US Agent

    Business Name
    Phadia US Inc.
    Contact Name
    Carla Krause
    Address
    4169 Commercial Avenue
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US
    Email
    [email protected]
    Phone
    616 2864138

    Products

    Device Name Product Code
    Anti-Rnp Antibody, Antigen And Control LKO
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM

    Proprietary Names

    EliA RNP70 Immunoassay EliA CENP Immunoassay EliA U1RNP Immunoassay Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E

    Establishment Types

    Manufacture Medical Device