BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EliA B2-Glycoprotein I IgG

    Reg #: 3004973408 · FEI: 3004973408 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PHADIA US INC.
    Registration Number
    3004973408
    FEI Number
    3004973408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4169 COMMERCIAL AVE.
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    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

    Complaint File Establishment per 21 CFR 820.198