Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1721937

FEI Number

1000117401

Entity Name

CORGENIX, INC.

City/State/Country

BROOMFIELD, CO, US

Establishment Address

11575 MAIN ST., SUITE 400, BROOMFIELD, CO 80020, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CORGENIX, INC. (Owner Number: 9001900)

Owner / Operator Contact Address

11575 MAIN ST., SUITE 400, Broomfield, CO 80020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K072032

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-27
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2007-12-27
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-27
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2007-12-27
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-27
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2007-12-27
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-27
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-27
OTQ	Research Use Only/Hematology Devices	Unknown	Class N	N/A	2017-06-22
OBW	11-Dehydro Thromboxane B2 Kit, Urinary	Hematology	Class 2	864.5700	2007-06-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-27
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2013-10-28
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-27
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2012-08-01
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2007-12-27
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2007-12-27
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-02-06
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2008-07-02

Official Correspondent

Souda Truong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CORGENIX, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721937. Last updated year: 2026. Please use registration number 1721937 when referencing this establishment in official correspondence.