BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PHADIA GMBH

    Reg #: 9680745 · FEI: 3005774014 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    15

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    Registration Details

    Registration Name
    PHADIA GMBH
    Registration Number
    9680745
    FEI Number
    3005774014
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MUNZINGER STRASSE 7
    City
    FREIBURG Baden-Wurttemberg
    Country
    DE

    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
    Antinuclear Antibody, Antigen, Control LKJ
    Antibodies, Gliadin MST
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody NYO
    Container, Specimen, Non-Sterile NNI
    Anti-Ribosomal P Antibodies MQA
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Test, Anticardiolipin Immunological MID
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Anti-Rnp Antibody, Antigen And Control LKO
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Anti-Sm Antibody, Antigen And Control LKP
    Agent, Clearing KEM
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX

    Proprietary Names

    EliA Ro52 EliA Ro60 EliA Gliadin DP IgA Well EliA Gliadin DP IgG Well ELIA CELIKEY IGG WELL Phadia 250 and Phadia 2500, Phadia 5000 Instrument E series EliA RNA Pol III EliA Stool Extraction Kit plus EliA Rib-P EliA Cardiolipin IgA Immunoassay EliA™ Scl-70S Immunoassay EliA SymphonyS Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA Jo-1 EliA RNP70 EliA ß2-Glycoprotein I IgA EliA SmDP-S EliA Stool Extraction Buffer plus Dilution Plate, Phadia 250 EliA CCP Positive Control 250 EliA Sample Diluent EliA Dummy Well EliA IgG Calibrator Well EliA CCP Well EliA CCP Positive Control 2500/5000 EliA IgG Curve Control Strips EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA IgG Calibrator Strips EliA La EliA Ro EliA CENP EliA U1RNP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)