Product code MSV
- Device name
- System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026-02-06 |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | 2018-06-25 |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | 2017-06-19 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | Inova Diagnostics, Inc. | 2015-12-21 |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | Inova Diagnostics, Inc. | 2015-02-13 |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | Phadia US, Inc. | 2012-06-22 |
| K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | Instrumentation Laboratory CO | 2010-05-21 |
| K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR | Thera-Test Laboratories, Inc. | 2009-10-09 |
| K072032 | IGG ANTI-ATHEROX TEST KIT | Corgenix, Inc. | 2008-04-04 |
| K062217 | AESKULSKA BETA2-GLYCO-A | Aesku, Inc. | 2006-12-13 |
| K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 | Pharmacia Deutschland GmbH | 2004-05-11 |
| K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | Pharmacia Deutschland GmbH | 2004-05-11 |
| K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 | Pharmacia Deutschland GmbH | 2004-05-11 |
| K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 | Pharmacia Deutschland GmbH | 2004-05-11 |
| K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | Immco Diagnostics, Inc. | 2003-09-09 |
| K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | Immco Diagnostics, Inc. | 2003-09-09 |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | Corgenix, Inc. | 2003-07-07 |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | Axis-Shield Diagnostics, Ltd. | 2003-06-19 |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | Hycor Biomedical , Ltd. | 2003-03-21 |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | Hycor Biomedical, Inc. | 2002-12-18 |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Hycor Biomedical, Inc. | 2002-12-18 |
| K021610 | QAB2A IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 |
| K021611 | QAB2A IGG ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 |
| K020695 | QAB2A IGG ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-04-19 |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Diamedix Corp. | 2002-01-08 |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-12-21 |
| K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | Corgenix, Inc. | 2001-09-28 |
| K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | Corgenix, Inc. | 2001-09-28 |
| K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | Corgenix, Inc. | 2001-09-28 |
| K991804 | BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. | The Binding Site, Ltd. | 2000-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426951011216 | HemosIL CL Anti-ß2 Glycoprotein-I IgM | INSTRUMENTATION LABORATORY COMPANY | 2026-04-08 |
| 08430793040716 | Aptiva® APS IgG Reagent | INOVA DIAGNOSTICS, INC. | 2024-03-11 |
| 08430793040853 | Aptiva® APS IgM Reagent | INOVA DIAGNOSTICS, INC. | 2024-03-11 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 07333066014760 | EliA ß2-Glycoprotein I IgM Well | Phadia AB | 2016-09-23 |
| 07333066014753 | EliA ß2-Glycoprotein I IgG Well | Phadia AB | 2016-09-23 |
| 07333066014746 | EliA ß2-Glycoprotein I IgA Well | Phadia AB | 2016-09-23 |
| 00847817018251 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018220 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018268 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018275 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018282 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000604 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000710 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002998 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012980 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012997 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018244 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018237 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018213 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018206 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950451112 | QUANTA Lite® β2GPI IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595816 | QUANTA Lite® β2GPI IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594659 | QUANTA Lite® β2GPI IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594543 | QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594529 | QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594482 | QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593157 | QUANTA Lite® β2GPI IgA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950485971 | QUANTA Lite® β2GPI IgM ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454472 | QUANTA Lite® β2GPI Screening ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |