System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA product code MSV · 44 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5660
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-06-24 – 2026-02-06

MSV 2026-02-06

Aptiva APS IgA Reagent

Applicant Inova Diagnostics, Inc.

K number K243979

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MSV 2018-06-25

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

Applicant Phadia AB

K number K181329

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MSV 2017-06-19

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

Applicant Immco Diagnostics, Inc.

K number K162788

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MSV 2012-06-22

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

Applicant Phadia US, Inc.

K number K112414

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MSV 2010-05-21

HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS

Applicant Instrumentation Laboratory CO

K number K091556

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MSV 2009-10-09

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR

Applicant Thera-Test Laboratories, Inc.

K number K092757

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MSV 2008-04-04

IGG ANTI-ATHEROX TEST KIT

Applicant Corgenix, Inc.

K number K072032

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MSV 2006-12-13

AESKULSKA BETA2-GLYCO-A

Applicant Aesku, Inc.

K number K062217

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MSV 2004-05-11

VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096

Applicant Pharmacia Deutschland GmbH

K number K040452

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MSV 2004-05-11

VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896

Applicant Pharmacia Deutschland GmbH

K number K040451

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MSV 2004-05-11

VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

Applicant Pharmacia Deutschland GmbH

K number K040450

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MSV 2004-05-11

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796

Applicant Pharmacia Deutschland GmbH

K number K040449

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MSV 2003-09-09

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

Applicant Immco Diagnostics, Inc.

K number K030702

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MSV 2003-09-09

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA

Applicant Immco Diagnostics, Inc.

K number K030701

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MSV 2003-07-07

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

Applicant Corgenix, Inc.

K number K031208

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MSV 2003-06-19

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

Applicant Axis-Shield Diagnostics, Ltd.

K number K031177

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MSV 2003-03-21

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

Applicant Hycor Biomedical , Ltd.

K number K030397

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MSV 2002-12-18

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA

Applicant Hycor Biomedical, Inc.

K number K022945

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MSV 2002-12-18

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA

Applicant Hycor Biomedical, Inc.

K number K022944

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MSV 2002-07-12

QAB2A IGG ELISA KIT HRP

Applicant Cheshire Diagnostics , Ltd.

K number K021611

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MSV 2002-07-12

QAB2A IGM ELISA KIT HRP

Applicant Cheshire Diagnostics , Ltd.

K number K021610

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MSV 2002-04-19

QAB2A IGG ELISA KIT

Applicant Cheshire Diagnostics , Ltd.

K number K020695

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MSV 2002-01-08

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN

Applicant Diamedix Corp.

K number K013956

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MSV 2001-12-21

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM

Applicant Diamedix Corp.

K number K013628

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MSV 2001-09-28

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

Applicant Corgenix, Inc.

K number K013080

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MSV 2001-09-28

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT

Applicant Corgenix, Inc.

K number K013079

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MSV 2001-09-28

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT

Applicant Corgenix, Inc.

K number K013077

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MSV 2000-05-05

BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.

Applicant The Binding Site, Ltd.

K number K991804

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MSV 2000-05-05

BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.

Applicant The Binding Site, Ltd.

K number K991803

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MSV 2000-05-05

BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT

Applicant The Binding Site, Ltd.

K number K991802

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MSV 2000-05-05

BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT

Applicant The Binding Site, Ltd.

K number K991801

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MSV 1999-08-30

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

Applicant Hemagen Diagnostics, Inc.

K number K992243

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MSV 1999-08-30

VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT

Applicant Hemagen Diagnostics, Inc.

K number K992241

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MSV 1999-08-30

VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT

Applicant Hemagen Diagnostics, Inc.

K number K992224

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MSV 1998-12-22

REAADS IGA ANTI-B2GP 1 TEST KIT

Applicant Corgenix, Inc.

K number K982434

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MSV 1998-12-07

REAADS IGM ANTI-B2GP1 TEST KIT

Applicant Corgenix, Inc.

K number K982433

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MSV 1998-12-07

REAADS IGG ANTI-B2GPI TEST KIT

Applicant Corgenix, Inc.

K number K982391

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MSV 1998-10-15

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

Applicant Shield Diagnostics, Ltd.

K number K982879

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MSV 1998-03-24

QUANTA LITE B2 GPI SCREEN

Applicant Inova Diagnostics, Inc.

K number K980230

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MSV 1997-12-05

EL-B2GP1SCR

Applicant Theratest Laboratories, Inc.

K number K973882

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MSV 1997-12-05

THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR

Applicant Theratest Laboratories, Inc.

K number K972790

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MSV 1997-10-20

QUANTA LITE B2GPI IGM

Applicant Inova Diagnostics, Inc.

K number K973014

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MSV 1997-10-20

QUANTA LITE B2 GPI IGA

Applicant Inova Diagnostics, Inc.

K number K973006

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MSV 1997-06-24

QUANTA LITE B2GPI IGG

Applicant Inova Diagnostics, Inc.

K number K970551

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