MSV · Class II · 21 CFR 866.5660

FDA Product Code MSV: System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

Leading manufacturers include Corgenix, Inc., Inova Diagnostics, Inc. and Pharmacia Deutschland GmbH.

46
Total
46
Cleared
133d
Avg days
1997
Since
46 devices
25–46 of 46
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956
Diamedix Corp.
Immunology · 39d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628
Diamedix Corp.
Immunology · 46d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080
Corgenix, Inc.
Immunology · 14d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804
The Binding Site, Ltd.
Immunology · 345d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434
Corgenix, Inc.
Immunology · 161d
Cleared Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
K982391
Corgenix, Inc.
Immunology · 151d
Cleared Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433
Corgenix, Inc.
Immunology · 146d
Cleared Oct 15, 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879
Shield Diagnostics, Ltd.
Immunology · 62d
Cleared Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
K980230
Inova Diagnostics, Inc.
Immunology · 61d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790
Theratest Laboratories, Inc.
Immunology · 130d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882
Theratest Laboratories, Inc.
Immunology · 52d
Cleared Oct 20, 1997
QUANTA LITE B2 GPI IGA
K973006
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 20, 1997
QUANTA LITE B2GPI IGM
K973014
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Jun 24, 1997
QUANTA LITE B2GPI IGG
K970551
Inova Diagnostics, Inc.
Immunology · 132d