BEUDAMED
    FDA Registration Inactive 🇸🇪 Sweden

    EliA B2-Glycoprotein I IgG

    · Expires 2025
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    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
    K091845

    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
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Test, Anticardiolipin Immunological MID

    Proprietary Names

    EliA B2-Glycoprotein I IgG EliA APS Positive Control 250 EliA Cardiolipin IgG EliA Cardiolipin IgM EliA B2-Glycoprotein I IgM EliA IgM Calibrator Strips EliA IgM Conjugate 50 EliA IgM Conjugate 200 EliA IgG/IgM/IgA Negative Control 250 EliA IgM Curve Control Strips EliA IgM Calibrator Well

    Establishment Types

    Manufacture Medical Device