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Antibodies, Gliadin

FDA product code MST · 42 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5750
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-05-30 – 2017-07-28

MST 2017-07-28

ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

Applicant Immco Diagnostics, Inc.

K number K163177

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MST 2013-12-05

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

Applicant Aesku Diagnostics

K number K132082

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MST 2012-12-14

GLIADIN IGA AND GLIADIN LGA

Applicant Grifols USA, LLC

K number K113377

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MST 2012-09-20

QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

Applicant Inova Diagnostics, Inc.

K number K113863

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MST 2011-10-20

QUANTA FLASH (TM) DGP SCREEN

Applicant Inova Diagnostics, Inc.

K number K111414

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MST 2010-08-13

ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01

Applicant Phadia US, Inc.

K number K093459

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MST 2010-02-04

IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K091522

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MST 2009-08-07

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)

Applicant Euroimmun Us, Inc.

K number K083053

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MST 2009-07-28

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)

Applicant Euroimmun Us, Inc.

K number K083052

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MST 2008-10-15

BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

Applicant The Binding Site, Ltd.

K number K081674

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MST 2007-03-14

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL

Applicant Phadia US, Inc.

K number K063775

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MST 2007-03-12

QUANTA LITE H-TTG/DGP SCREEN

Applicant Inova Diagnostics, Inc.

K number K070083

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MST 2006-12-13

QUANTA LITE CELIAC DGP SCREEN

Applicant Inova Diagnostics, Inc.

K number K062708

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MST 2006-03-29

FIDIS CELIAC

Applicant Biomedical Diagnostics (Bmd) SA

K number K053383

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MST 2006-02-07

IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02

Applicant Pharmacia Diagnostics AB

K number K052793

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MST 2006-02-07

AESKULISA GLIA A AND AESKULISA GLIA G

Applicant Aesku Diagnostics

K number K052439

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MST 2005-10-04

QUANTA LITE GLIADIN IGA II

Applicant Inova Diagnostics, Inc.

K number K052143

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MST 2005-10-04

QUANTA LITE GLIADIN IGG II

Applicant Inova Diagnostics, Inc.

K number K052142

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MST 2004-09-24

FIDIS CELIAC

Applicant Biomedical Diagnostics S.A.

K number K041002

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MST 2004-08-02

VARELISA GLIADIN IGG ANTIBODIES

Applicant Sweden Diagnostics (Germany) GmbH

K number K041357

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MST 2004-07-16

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

Applicant Sweden Diagnostics (Germany) GmbH

K number K041354

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MST 2001-09-28

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

Applicant Diamedix Corp.

K number K012797

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MST 2001-09-28

DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

Applicant Diamedix Corp.

K number K012795

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MST 2000-10-19

MDI GLIADIN G TEST

Applicant Micro Detect, Inc.

K number K002359

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MST 2000-10-19

MDI GLIADIN A TEST

Applicant Micro Detect, Inc.

K number K002358

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MST 2000-10-19

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

Applicant Scimedx Corp.

K number K002189

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MST 2000-10-19

GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

Applicant Scimedx Corp.

K number K002169

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MST 2000-06-07

THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR

Applicant Zeus Scientific, Inc.

K number K001393

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MST 1999-11-12

THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.

Applicant Zeus Scientific, Inc.

K number K993250

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MST 1999-11-12

AUTOSTAT II ANTI-GLIADIN IGG ELISA

Applicant Cogent Diagnotics , Ltd.

K number K993087

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MST 1999-11-12

AUTOSTAT II ANTI-GLIADIN IGA ELISA

Applicant Cogent Diagnotics , Ltd.

K number K993086

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MST 1999-03-26

GLIADIN IGA ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K990207

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MST 1999-03-26

GLIADIN IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K990204

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MST 1999-02-17

GLIADIN ANTIBODIES ELISA

Applicant Genesis Diagnostics , Ltd.

K number K973910

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MST 1998-10-22

UNICAP GLIADIN IGG ASSAY

Applicant Pharmacia & Upjohn Co.

K number K982701

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MST 1998-10-22

UNICAP GLIADIN IGA ASSAY

Applicant Pharmacia & Upjohn Co.

K number K982533

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MST 1998-09-03

BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT

Applicant The Binding Site, Ltd.

K number K981929

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MST 1998-09-03

BINDAZYME ANTIGLIADIN IGG

Applicant The Binding Site, Ltd.

K number K981644

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MST 1997-06-02

QUANTA LITE IGA GLIADIN ELISA

Applicant Inova Diagnostics, Inc.

K number K964986

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MST 1997-05-30

QUANTA LITE IGG GLIADIN ELISA

Applicant Inova Diagnostics, Inc.

K number K964985

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MST 1997-05-30

IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

Applicant Immco Diagnostics, Inc.

K number K964344

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MST 1997-05-30

IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT

Applicant Immco Diagnostics, Inc.

K number K964341

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