BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORGENIX, INC.

    Reg #: 1721937 · FEI: 1000117401 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    34
    Establishment Types
    4
    Classifications
    10

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    Registration Details

    Registration Name
    CORGENIX, INC.
    Registration Number
    1721937
    FEI Number
    1000117401
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11575 MAIN ST., SUITE 400
    City
    BROOMFIELD
    State
    CO
    ZIP
    80020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024196

    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, Anticardiolipin Immunological MID
    Plasma, Control, Normal GIZ
    Test, Qualitative And Quantitative Factor Deficiency GGP
    System, Test, Systemic Lupus Erythematosus DHC
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Research Use Only/Hematology Devices OTQ
    11-Dehydro Thromboxane B2 Kit, Urinary OBW
    Control, Plasma, Abnormal GGC
    Research Use Only/Clinical Chemistry Devices OTV
    Galectin-3 In Vitro Diagnostic Assay OSX

    Proprietary Names

    REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) REAADS COAGULATION CONTROL 1 REAADS Protein S Antigen Test Kit Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit Corgenix anti-Beta-2 Glycoprotein IgM Semi-Quantitative Test Kit Corgenix anti-Phosphatidylserine IgG Semi-Quantitative Test Kit Corgenix anti-Beta-2 Glycoprotein IgG Semi-Quantitative Test Kit Corgenix anti-Cardiolipin IgM Semi-Quantitative Test Kit Corgenix anti-Cardiolipin IgG 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 REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) REAADS Anti-Cardiolipin IgA Semi-Quantitative Test Kit Corgenix Collagen Binding Assay Corgenix AspirinWorks Test Kit Corgenix 11dhTxB2 Test Kit REAADS von Willebrand Factor Activity Test Kit REAADS Coagulation Control 2 REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit Corgenix TGF-B1 Test Kit ELISA Anti IL-23 ELISA Test Kit Anti VEGF-D ELISA Test KIt Corgenix HA ELISA Test Kit REAADS anti-Beta-2 Glycoprotein I IgM Semi-Quantitative Test Kit REAADS anti-Beta-2 Glycoprotein I IgA Semi-Quantitative Test Kit REAADS anti-Prothrombin IgG Semi-Quantitative Test Kit REAADS anti-Beta-2 Glycoprotein I IgG Semi-Quantitative Test Kit REAADS Collagen Binding Test Anti-AtherOx IgG Test Kit (IgG anti-oxLDL-B2GPI) REAADS von Willerand Factor Antigen Test Kit REAADS Protein C Antigen Test Kit Galectin 3 REAADS Monoclonal Free Protein S Antigen Test Kit

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)