Panels › Immunology › Product code MSV · Class 2
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Regulation 866.5660
1510(k)s in 12 months (46 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MSV
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2026 | K243979 | Aptiva APS IgA Reagent Inova Diagnostics, Inc. | MSV |
| Jun 25, 2018 | K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB, SE | MSV |
| Jun 19, 2017 | K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Anti Immco Diagnostics, Inc. | MSV |
| Dec 21, 2015 | K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar An Inova Diagnostics, Inc. | MSV |
| Feb 13, 2015 | K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. Inova Diagnostics, Inc. | MSV |
| Jun 22, 2012 | K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY Phadia US, Inc. | MSV |
| May 21, 2010 | K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS Instrumentation Laboratory CO | MSV |
| Oct 9, 2009 | K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR Thera-Test Laboratories, Inc. | MSV |
| Apr 4, 2008 | K072032 | IGG ANTI-ATHEROX TEST KIT Corgenix, Inc. | MSV |
| Dec 13, 2006 | K062217 | AESKULSKA BETA2-GLYCO-A Aesku, Inc. | MSV |
| May 11, 2004 | K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 Pharmacia Deutschland GmbH, DE | MSV |
| May 11, 2004 | K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 Pharmacia Deutschland GmbH, DE | MSV |
| May 11, 2004 | K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 Pharmacia Deutschland GmbH, DE | MSV |
| May 11, 2004 | K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 Pharmacia Deutschland GmbH, DE | MSV |
| Sep 9, 2003 | K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA Immco Diagnostics, Inc. | MSV |
| Sep 9, 2003 | K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA Immco Diagnostics, Inc. | MSV |
| Jul 7, 2003 | K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 Corgenix, Inc. | MSV |
| Jun 19, 2003 | K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M Axis-Shield Diagnostics, Ltd., GB | MSV |
| Mar 21, 2003 | K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA Hycor Biomedical , Ltd., GB | MSV |
| Dec 18, 2002 | K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA Hycor Biomedical, Inc. | MSV |
| Dec 18, 2002 | K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA Hycor Biomedical, Inc. | MSV |
| Jul 12, 2002 | K021611 | QAB2A IGG ELISA KIT HRP Cheshire Diagnostics , Ltd., GB | MSV |
| Jul 12, 2002 | K021610 | QAB2A IGM ELISA KIT HRP Cheshire Diagnostics , Ltd., GB | MSV |
| Apr 19, 2002 | K020695 | QAB2A IGG ELISA KIT Cheshire Diagnostics , Ltd., GB | MSV |
| Jan 8, 2002 | K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN Diamedix Corp. | MSV |
| Dec 21, 2001 | K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM Diamedix Corp. | MSV |
| Sep 28, 2001 | K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT Corgenix, Inc. | MSV |
| Sep 28, 2001 | K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT Corgenix, Inc. | MSV |
| Sep 28, 2001 | K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT Corgenix, Inc. | MSV |
| May 5, 2000 | K991804 | BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. The Binding Site, Ltd. | MSV |
| May 5, 2000 | K991803 | BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. The Binding Site, Ltd. | MSV |
| May 5, 2000 | K991802 | BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT The Binding Site, Ltd. | MSV |
| May 5, 2000 | K991801 | BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT The Binding Site, Ltd. | MSV |
| Aug 30, 1999 | K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Aug 30, 1999 | K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Aug 30, 1999 | K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Dec 22, 1998 | K982434 | REAADS IGA ANTI-B2GP 1 TEST KIT Corgenix, Inc. | MSV |
| Dec 7, 1998 | K982433 | REAADS IGM ANTI-B2GP1 TEST KIT Corgenix, Inc. | MSV |
| Dec 7, 1998 | K982391 | REAADS IGG ANTI-B2GPI TEST KIT Corgenix, Inc. | MSV |
| Oct 15, 1998 | K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY Shield Diagnostics, Ltd., GB | MSV |
| Mar 24, 1998 | K980230 | QUANTA LITE B2 GPI SCREEN Inova Diagnostics, Inc. | MSV |
| Dec 5, 1997 | K973882 | EL-B2GP1SCR Theratest Laboratories, Inc. | MSV |
| Dec 5, 1997 | K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR Theratest Laboratories, Inc. | MSV |
| Oct 20, 1997 | K973014 | QUANTA LITE B2GPI IGM Inova Diagnostics, Inc. | MSV |
| Oct 20, 1997 | K973006 | QUANTA LITE B2 GPI IGA Inova Diagnostics, Inc. | MSV |
| Jun 24, 1997 | K970551 | QUANTA LITE B2GPI IGG Inova Diagnostics, Inc. | MSV |
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