IGG ANTI-ATHEROX TEST KIT
CORGENIX, INC.
CORGENIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1721937 | 1000117401 | CORGENIX, INC. | 1 | N | 2026-01-01 | 11575 MAIN ST. SUITE 400 BROOMFIELD CO US 80020 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 12258 | 1126549045 | K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT | GGP | 1998-12-22 |
| 12258 | 1015559440 | K972482 | REAADS PROTEIN S ANTIGEN TEST KIT | GGP | 1997-08-13 |
| 12258 | 2049040628 | K972342 | REAADS PROTEIN C ANTIGEN TEST KIT | GGP | 1997-10-06 |
| 12258 | 2035167824 | K972005 | REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT | GGP | 1997-08-13 |
| 12258 | 1907520978 | K941737 | SPECIALTY ASSAYED CONTROL-1 | GIZ | 1994-10-07 |
| 12258 | 1191267762 | K100103 | SPECIALTY ASSAYED CONTROL-2 | GGC | 2010-12-15 |
| 12258 | 1100938799 | K093758 | BGM GALECTIN -3 | OSX | 2010-11-17 |
| 12258 | 1307081399 | K072032 | IGG ANTI-ATHEROX TEST KIT | MSV | 2008-04-04 |
| 12258 | 1073627776 | K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | OBW | 2007-05-29 |
| 12258 | 1222324038 | K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | MID | 2003-10-14 |
| 12258 | 1835356731 | K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | GGP | 2004-04-05 |
| 12258 | 1514203252 | K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | MSV | 2003-07-07 |
| 12258 | 1140191451 | K030477 | DIADEXUS PLAC TEST | NOE | 2003-07-18 |
| 12258 | 1423632341 | K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | MID | 2003-01-03 |
| 12258 | 1315120169 | K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | MID | 2003-01-03 |
| 12258 | 1089805967 | K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | MID | 2002-09-25 |
| 12258 | 1805876937 | K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | MID | 2002-09-25 |
| 12258 | 1811877764 | ||||
| 12258 | 1858496617 | ||||
| 12258 | 1914850638 |
Product Codes Associated With Registrations#
PMN#
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
CORGENIX, INC.
RHIGENE HEP-ANA TEST SYSTEM
CORGENIX, INC.
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
CORGENIX, INC.
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
CORGENIX, INC.
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
CORGENIX, INC.
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
CORGENIX, INC.
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
CORGENIX, INC.
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
CORGENIX, INC.
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
CORGENIX, INC.
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
CORGENIX, INC.
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
CORGENIX, INC.
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
CORGENIX, INC.
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.
REAADS IGA ANTI-B2GP 1 TEST KIT
CORGENIX, INC.
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
CORGENIX, INC.
REAADS IGM ANTI-B2GP1 TEST KIT
CORGENIX, INC.
REAADS IGG ANTI-B2GPI TEST KIT
CORGENIX, INC.