Atlas FDA

MSV

46 FDA 510(k) clearances · Product code

81 daysmedian time to decision
345 days90th percentile
46clearances measured

FDA profile

Official device name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
Aptiva APS IgA Reagent (K243979)Inova Diagnostics, Inc.2026-02-06
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329)Phadia AB2018-06-25
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 (K162788)Immco Diagnostics, Inc.2017-06-19
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875)Inova Diagnostics, Inc.2015-12-21
QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. (K141274)Inova Diagnostics, Inc.2015-02-13
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (K112414)Phadia US, Inc.2012-06-22
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (K091556)Instrumentation Laboratory CO2010-05-21
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (K092757)Thera-Test Laboratories, Inc.2009-10-09
IGG ANTI-ATHEROX TEST KIT (K072032)Corgenix, Inc.2008-04-04
AESKULSKA BETA2-GLYCO-A (K062217)Aesku, Inc.2006-12-13
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (K040451)Pharmacia Deutschland GmbH2004-05-11
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (K040449)Pharmacia Deutschland GmbH2004-05-11
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (K040450)Pharmacia Deutschland GmbH2004-05-11
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (K040452)Pharmacia Deutschland GmbH2004-05-11
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA (K030701)Immco Diagnostics, Inc.2003-09-09
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA (K030702)Immco Diagnostics, Inc.2003-09-09
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 (K031208)Corgenix, Inc.2003-07-07
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M (K031177)Axis-Shield Diagnostics, Ltd.2003-06-19
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA (K030397)Hycor Biomedical , Ltd.2003-03-21
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA (K022945)Hycor Biomedical, Inc.2002-12-18
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA (K022944)Hycor Biomedical, Inc.2002-12-18
QAB2A IGM ELISA KIT HRP (K021610)Cheshire Diagnostics , Ltd.2002-07-12
QAB2A IGG ELISA KIT HRP (K021611)Cheshire Diagnostics , Ltd.2002-07-12
QAB2A IGG ELISA KIT (K020695)Cheshire Diagnostics , Ltd.2002-04-19
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (K013956)Diamedix Corp.2002-01-08
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (K013628)Diamedix Corp.2001-12-21
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT (K013080)Corgenix, Inc.2001-09-28
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT (K013079)Corgenix, Inc.2001-09-28
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT (K013077)Corgenix, Inc.2001-09-28
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT (K991802)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT (K991801)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. (K991803)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. (K991804)The Binding Site, Ltd.2000-05-05
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT (K992241)Hemagen Diagnostics, Inc.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT (K992224)Hemagen Diagnostics, Inc.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT (K992243)Hemagen Diagnostics, Inc.1999-08-30
REAADS IGA ANTI-B2GP 1 TEST KIT (K982434)Corgenix, Inc.1998-12-22
REAADS IGG ANTI-B2GPI TEST KIT (K982391)Corgenix, Inc.1998-12-07
REAADS IGM ANTI-B2GP1 TEST KIT (K982433)Corgenix, Inc.1998-12-07
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (K982879)Shield Diagnostics, Ltd.1998-10-15
QUANTA LITE B2 GPI SCREEN (K980230)Inova Diagnostics, Inc.1998-03-24
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR (K972790)Theratest Laboratories, Inc.1997-12-05
EL-B2GP1SCR (K973882)Theratest Laboratories, Inc.1997-12-05
QUANTA LITE B2GPI IGM (K973014)Inova Diagnostics, Inc.1997-10-20
QUANTA LITE B2 GPI IGA (K973006)Inova Diagnostics, Inc.1997-10-20
QUANTA LITE B2GPI IGG (K970551)Inova Diagnostics, Inc.1997-06-24

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