BEUDAMED
    FDA Registration Inactive 🇸🇪 Sweden

    EliA IgG Conjugate 50

    · Expires 2025
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHADIA AB
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Almungevagen 35
    City
    Uppsala
    Country
    SE

    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

    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