BEUDAMED
    FDA Registration Inactive 🇸🇪 Sweden

    EliA Cardiolipin IgA Immunoassay

    · Expires 2025
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K131821

    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
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Test, Anticardiolipin Immunological MID

    Proprietary Names

    EliA Cardiolipin IgA Immunoassay

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)