FDA Product Code
FDA Product Code MSV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | 2018-06-25 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | Inova Diagnostics, Inc. | 2015-02-13 | Traditional | PDF ↗ |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | Phadia US, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | Instrumentation Laboratory CO | 2010-05-21 | Traditional | PDF ↗ |
| K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR | Thera-Test Laboratories, Inc. | 2009-10-09 | Special | PDF ↗ |
| K072032 | IGG ANTI-ATHEROX TEST KIT | Corgenix, Inc. | 2008-04-04 | Traditional | PDF ↗ |
| K062217 | AESKULSKA BETA2-GLYCO-A | Aesku, Inc. | 2006-12-13 | Traditional | PDF ↗ |
| K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 | Pharmacia Deutschland GmbH | 2004-05-11 | Traditional | PDF ↗ |
| K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 | Pharmacia Deutschland GmbH | 2004-05-11 | Traditional | PDF ↗ |
| K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 | Pharmacia Deutschland GmbH | 2004-05-11 | Traditional | PDF ↗ |
| K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | Pharmacia Deutschland GmbH | 2004-05-11 | Traditional | PDF ↗ |
| K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | Immco Diagnostics, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | Immco Diagnostics, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | Corgenix, Inc. | 2003-07-07 | Special | PDF ↗ |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | Axis-Shield Diagnostics, Ltd. | 2003-06-19 | Traditional | PDF ↗ |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | Hycor Biomedical , Ltd. | 2003-03-21 | Traditional | PDF ↗ |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Hycor Biomedical, Inc. | 2002-12-18 | Traditional | PDF ↗ |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | Hycor Biomedical, Inc. | 2002-12-18 | Traditional | PDF ↗ |
| K021610 | QAB2A IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | Traditional | PDF ↗ |
| K021611 | QAB2A IGG ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | Traditional | PDF ↗ |
| K020695 | QAB2A IGG ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-04-19 | Traditional | PDF ↗ |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Diamedix Corp. | 2002-01-08 | Traditional | PDF ↗ |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-12-21 | Traditional | PDF ↗ |
| K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | Corgenix, Inc. | 2001-09-28 | Special | PDF ↗ |
| K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | Corgenix, Inc. | 2001-09-28 | Special | PDF ↗ |
| K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | Corgenix, Inc. | 2001-09-28 | Special | PDF ↗ |
| K991804 | BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. | The Binding Site, Ltd. | 2000-05-05 | Traditional | PDF ↗ |
| K991803 | BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. | The Binding Site, Ltd. | 2000-05-05 | Traditional | PDF ↗ |
| K991801 | BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT | The Binding Site, Ltd. | 2000-05-05 | Traditional | PDF ↗ |
| K991802 | BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT | The Binding Site, Ltd. | 2000-05-05 | Traditional | PDF ↗ |
| K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K982434 | REAADS IGA ANTI-B2GP 1 TEST KIT | Corgenix, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K982391 | REAADS IGG ANTI-B2GPI TEST KIT | Corgenix, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K982433 | REAADS IGM ANTI-B2GP1 TEST KIT | Corgenix, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1998-10-15 | Traditional | PDF ↗ |
| K980230 | QUANTA LITE B2 GPI SCREEN | Inova Diagnostics, Inc. | 1998-03-24 | Traditional | PDF ↗ |
| K973882 | EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K973006 | QUANTA LITE B2 GPI IGA | Inova Diagnostics, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K973014 | QUANTA LITE B2GPI IGM | Inova Diagnostics, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K970551 | QUANTA LITE B2GPI IGG | Inova Diagnostics, Inc. | 1997-06-24 | Traditional | PDF ↗ |
Product code MSV · Class II · Immunology. Data: openFDA.