Corgenix Inc

FDA Filings

This page includes the latest FDA filings for Corgenix Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Corgenix Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Daniel Simpson

FDA Registration(s)

• Registration Number: 1721937
• FEI Number: 1000117401
• Name: CORGENIX, INC.
• Owner & Operator: CORGENIX, INC.
• Contact Address: 11575 MAIN ST. SUITE 400; Broomfield CO 80020 US
• Official Correspondent:
  • Daniel F Simpson
  • x-303-4574345-128
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11575 MAIN ST. SUITE 400; BROOMFIELD, CO 80020 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
OTQ CORGENIX, INC.	Corgenix Collagen Binding Assay	2017-06-22
PMN K100103 | GGC CORGENIX, INC.	REAADS Coagulation Control 2	2013-10-28
PMN K093758 | OSX CORGENIX, INC.	Galectin 3	2012-10-30
PMN K030477 | NOE CORGENIX, INC.	PLAC Test ELISA Kit	2012-10-30
PMN K030477 | JJX CORGENIX, INC.	PLAC Test ELISA Kit	2012-10-30
OTV CORGENIX, INC.	Corgenix TGF-B1 Test Kit ELISA	2012-08-01
OTV CORGENIX, INC.	Corgenix HA ELISA Test Kit	2012-08-01
OTV CORGENIX, INC.	Anti VEGF-D ELISA Test KIt	2012-08-01
OTV CORGENIX, INC.	Anti IL-23 ELISA Test Kit	2012-08-01
GGP CORGENIX, INC.	REAADS Collagen Binding Test	2012-02-06
PMN K072032 | MSV CORGENIX, INC.	Anti-AtherOx IgG Test Kit (IgG anti-oxLDL-B2GPI)	2008-07-02
PMN K072032 CORGENIX, INC.	IGG ANTI-ATHEROX TEST KIT	2008-04-04
PMN K983914 | GGP CORGENIX, INC.	REAADS Monoclonal Free Protein S Antigen Test Kit	2007-12-27
PMN K972482 | GGP CORGENIX, INC.	REAADS Protein S Antigen Test Kit	2007-12-27
PMN K972342 | GGP CORGENIX, INC.	REAADS Protein C Antigen Test Kit	2007-12-27
PMN K972005 | GGP CORGENIX, INC.	REAADS von Willerand Factor Antigen Test Kit	2007-12-27
PMN K941737 | GIZ CORGENIX, INC.	REAADS COAGULATION CONTROL 1	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Cardiolipin IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Cardiolipin IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Cardiolipin IgA Semi Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MSV CORGENIX, INC.	Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Cardiolipin IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Cardiolipin IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Cardiolipin IgA Semi Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | MID CORGENIX, INC.	Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Phosphatidylserine IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Cardiolipin IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Cardiolipin IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Cardiolipin IgA Semi Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgM Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix anti-Beta-2 Glycoprotein IgG Semi-Quantitative Test Kit	2007-12-27
PMN K032868 | DHC CORGENIX, INC.	Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit	2007-12-27
PMN K032139 | GGP CORGENIX, INC.	REAADS von Willebrand Factor Activity Test Kit	2007-12-27
PMN K031208 | MSV CORGENIX, INC.	REAADS anti-Prothrombin IgG Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | MSV CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgM Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | MSV CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgG Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | MSV CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgA Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | DHC CORGENIX, INC.	REAADS anti-Prothrombin IgG Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | DHC CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgM Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | DHC CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgG Semi-Quantitative Test Kit	2007-12-27
PMN K031208 | DHC CORGENIX, INC.	REAADS anti-Beta-2 Glycoprotein I IgA Semi-Quantitative Test Kit	2007-12-27
PMN K024196 | MID CORGENIX, INC.	REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well)	2007-12-27
PMN K024195 | MID CORGENIX, INC.	REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well)	2007-12-27
PMN K022992 | MID CORGENIX, INC.	REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit	2007-12-27
PMN K022990 | MID CORGENIX, INC.	REAADS Anti-Cardiolipin IgA Semi-Quantitative Test Kit	2007-12-27
PMN K062025 | OBW CORGENIX, INC.	Corgenix AspirinWorks Test Kit	2007-06-04
PMN K062025 | OBW CORGENIX, INC.	Corgenix 11dhTxB2 Test Kit	2007-06-04
PMN K062025 CORGENIX, INC.	ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136	2007-05-29
PMN K042680 CORGENIX, INC.	RHIGENE HEP-ANA TEST SYSTEM	2004-11-19
PMN K032139 CORGENIX, INC.	REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826	2004-04-05
PMN K034013 CORGENIX, INC.	REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001	2004-01-08
PMN K032868 CORGENIX, INC.	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139	2003-10-14
PMN K031208 CORGENIX, INC.	REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001	2003-07-07
PMN K024196 CORGENIX, INC.	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	2003-01-03
PMN K024195 CORGENIX, INC.	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT	2003-01-03
PMN K022992 CORGENIX, INC.	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001	2002-09-25
PMN K022990 CORGENIX, INC.	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001	2002-09-25
PMN K013080 CORGENIX, INC.	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT	2001-09-28
PMN K013079 CORGENIX, INC.	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT	2001-09-28
PMN K013077 CORGENIX, INC.	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT	2001-09-28
PMN K012567 CORGENIX, INC.	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	2001-08-23
PMN K001398 CORGENIX, INC.	REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	2001-03-30
PMN K000920 CORGENIX, INC.	REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT	2000-04-26
PMN K983914 CORGENIX, INC.	REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT	1998-12-22
PMN K982434 CORGENIX, INC.	REAADS IGA ANTI-B2GP 1 TEST KIT	1998-12-22
PMN K982433 CORGENIX, INC.	REAADS IGM ANTI-B2GP1 TEST KIT	1998-12-07
PMN K982391 CORGENIX, INC.	REAADS IGG ANTI-B2GPI TEST KIT	1998-12-07