System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
FDA product code MSV · Class II (moderate risk) · 21 CFR 866.5660 · Immunology
46510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Corgenix, Inc. 8
- Inova Diagnostics, Inc. 7
- Pharmacia Deutschland GmbH 4
- The Binding Site, Ltd. 4
- Hemagen Diagnostics, Inc. 3
- Immco Diagnostics, Inc. 3
- Cheshire Diagnostics , Ltd. 3
- Hycor Biomedical, Inc. 3
- Theratest Laboratories, Inc. 2
- Diamedix Corp. 2
- Axis-Shield Diagnostics, Ltd. 1
- Shield Diagnostics, Ltd. 1
- Aesku, Inc. 1
- Thera Test Laboratories, Inc. 1
- Instrumentation Laboratory CO 1
- Phadia US, Inc. 1
- Phadia AB 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243979 | Aptiva APS IgA ReagentMSV · Traditional | Inova Diagnostics, Inc. | 02/06/2026SE |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV · Traditional | Phadia AB | 06/25/2018SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | Immco Diagnostics, Inc. | 06/19/2017SE |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar…MSV · Traditional | Inova Diagnostics, Inc. | 12/21/2015SE |
| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar ANTI-¿2GPI DOMAIN1; Controls.MSV · Traditional | Inova Diagnostics, Inc. | 02/13/2015SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | Phadia US, Inc. | 06/22/2012SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | Instrumentation Laboratory CO | 05/21/2010SE |
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
| K040452 | Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
| K040451 | Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
| K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
| K040449 | Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
| K030702 | Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm ElisaMSV · Traditional | Immco Diagnostics, Inc. | 09/09/2003SE |
| K030701 | Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igg ElisaMSV · Traditional | Immco Diagnostics, Inc. | 09/09/2003SE |
| K031208 | Reaads Igm ANTI-B2GPI Test Kit, Model 038-001MSV · Special | Corgenix, Inc. | 07/07/2003SE |
| K031177 | Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100MMSV · Traditional | Axis-Shield Diagnostics, Ltd. | 06/19/2003SE |
| K030397 | Autostat II ANTI-B-2 Glycoprotein I Iga ElisaMSV · Traditional | Hycor Biomedical , Ltd. | 03/21/2003SE |
| K022945 | Autostat II ANTI-B-2 Glycoprotein I Igg ElisaMSV · Traditional | Hycor Biomedical, Inc. | 12/18/2002SE |
| K022944 | Autostat II ANTI-B-2 Glycoprotein-I Igm ElisaMSV · Traditional | Hycor Biomedical, Inc. | 12/18/2002SE |
| K021611 | QAB2A Igg Elisa Kit HRPMSV · Traditional | Cheshire Diagnostics , Ltd. | 07/12/2002SE |
| K021610 | QAB2A Igm Elisa Kit HRPMSV · Traditional | Cheshire Diagnostics , Ltd. | 07/12/2002SE |
| K020695 | QAB2A Igg Elisa KitMSV · Traditional | Cheshire Diagnostics , Ltd. | 04/19/2002SE |
| K013956 | Diamedix IS-ANTI-B2 Glycoprotein I ScreenMSV · Traditional | Diamedix Corp. | 01/08/2002SE |
| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | Diamedix Corp. | 12/21/2001SE |
| K013080 | Reaads Anti-Beta 2 Glycoprotein I Igg Test KitMSV · Special | Corgenix, Inc. | 09/28/2001SE |
| K013079 | Reaads Anti-Beta 2 Glycoprotein I Iga Test KitMSV · Special | Corgenix, Inc. | 09/28/2001SE |
| K013077 | Reaads Anti-Beta 2 Glycoprotein I Igm Test KitMSV · Special | Corgenix, Inc. | 09/28/2001SE |
| K991804 | Bindazyme ANTI-B2 Screen Eia Test Kit.MSV · Traditional | The Binding Site, Ltd. | 05/05/2000SE |
| K991803 | Bindazyme Anti B2 GP1 Igm Eia Test Kit.MSV · Traditional | The Binding Site, Ltd. | 05/05/2000SE |
| K991802 | Bindazyme ANTI-B2 GP1 Iga Eia Test KitMSV · Traditional | The Binding Site, Ltd. | 05/05/2000SE |
| K991801 | Bindazyme ANTI-B2 GP1 Igg Eia Test KitMSV · Traditional | The Binding Site, Ltd. | 05/05/2000SE |
| K992243 | Virgo Beta 2 Glycoprotein Igm Antibody KitMSV · Traditional | Hemagen Diagnostics, Inc. | 08/30/1999SE |
| K992241 | Virgo B2 Glycoprotein I Iga Antibody KitMSV · Traditional | Hemagen Diagnostics, Inc. | 08/30/1999SE |
| K992224 | Virgo Beta 2 Glycoprotein Igg Antibody KitMSV · Traditional | Hemagen Diagnostics, Inc. | 08/30/1999SE |
| K982434 | Reaads Iga ANTI-B2GP 1 Test KitMSV · Traditional | Corgenix, Inc. | 12/22/1998SE |
| K982433 | Reaads Igm ANTI-B2GP1 Test KitMSV · Traditional | Corgenix, Inc. | 12/07/1998SE |
| K982391 | Reaads Igg ANTI-B2GPI Test KitMSV · Traditional | Corgenix, Inc. | 12/07/1998SE |
| K982879 | Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) AssayMSV · Traditional | Shield Diagnostics, Ltd. | 10/15/1998SE |
| K980230 | Quanta Lite B2 Gpi ScreenMSV · Traditional | Inova Diagnostics, Inc. | 03/24/1998SE |
| K973882 | EL-B2GP1SCRMSV · Traditional | Theratest Laboratories, Inc. | 12/05/1997SE |
| K972790 | The Theratest EL-B2GP1 (Igm, Igg, Iga) and EL-B2GP1SCRMSV · Traditional | Theratest Laboratories, Inc. | 12/05/1997SE |
| K973014 | Quanta Lite B2GPI IgmMSV · Traditional | Inova Diagnostics, Inc. | 10/20/1997SE |
| K973006 | Quanta Lite B2 Gpi IgaMSV · Traditional | Inova Diagnostics, Inc. | 10/20/1997SE |
| K970551 | Quanta Lite B2GPI IggMSV · Traditional | Inova Diagnostics, Inc. | 06/24/1997SE |