BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EliA IgG Conjugate 50

    Reg #: 9680745 · FEI: 3005774014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHADIA GMBH
    Registration Number
    9680745
    FEI Number
    3005774014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MUNZINGER STRASSE 7
    City
    FREIBURG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K061165

    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
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX

    Proprietary Names

    EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA Dummy Well EliA CCP Well Dilution Plate, Phadia 250 EliA IgG Calibrator Strips EliA Sample Diluent EliA CCP Positive Control 2500/5000 Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA CCP Positive Control 250 EliA IgG Calibrator Well EliA IgG Curve Control Strips

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)