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    FDA Registration Active 🇺🇸 United States

    Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit

    Reg #: 1721937 · FEI: 1000117401 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CORGENIX, INC.
    Registration Number
    1721937
    FEI Number
    1000117401
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11575 MAIN ST., SUITE 400
    City
    BROOMFIELD
    State
    CO
    ZIP
    80020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032868

    Owner / Operator

    Firm Name
    CORGENIX, INC.
    Operator Number
    9001900
    Address
    11575 MAIN ST., SUITE 400
    City
    Broomfield
    State
    CO
    Postal Code
    80020
    Country
    US
    Correspondent
    Souda Truong

    Products

    Device Name Product Code
    System, Test, Systemic Lupus Erythematosus DHC
    System, Test, Anticardiolipin Immunological MID
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV

    Proprietary Names

    Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit Corgenix anti-Cardiolipin IgM Semi-Quantitative Test Kit Corgenix anti-Cardiolipin IgG Semi-Quantitative Test Kit Corgenix anti-Beta-2 Glycoprotein IgM Semi-Quantitative Test Kit Corgenix anti-Cardiolipin IgA Semi Quantitative Test Kit Corgenix anti-Phosphatidylserine IgM Semi-Quantitative Test Kit Corgenix anti-Phosphatidylserine IgA Semi-Quantitative Test Kit Corgenix anti-Beta-2 Glycoprotein IgG Semi-Quantitative Test Kit Corgenix anti-Phosphatidylserine IgG Semi-Quantitative Test Kit

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device