MST · Class II · 21 CFR 866.5750

FDA Product Code MST: Antibodies, Gliadin

Leading manufacturers include Inova Diagnostics, Inc., Immco Diagnostics, Inc. and Zeus Scientific, Inc..

42
Total
42
Cleared
141d
Avg days
1997
Since

FDA 510(k) Cleared Antibodies, Gliadin Devices (Product Code MST)

42 devices
1–24 of 42
Cleared Jul 28, 2017
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
K163177
Immco Diagnostics, Inc.
Immunology · 256d
Cleared Dec 05, 2013
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082
Aesku Diagnostics
Immunology · 153d
Cleared Dec 14, 2012
GLIADIN IGA AND GLIADIN LGA
K113377
Grifols USA, LLC
Immunology · 394d
Cleared Sep 20, 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
K113863
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
K111414
Inova Diagnostics, Inc.
Immunology · 153d
Cleared Aug 13, 2010
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K093459
Phadia US, Inc.
Immunology · 280d
Cleared Feb 04, 2010
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522
Immco Diagnostics, Inc.
Immunology · 258d
Cleared Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053
Euroimmun Us, Inc.
Immunology · 297d
Cleared Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052
Euroimmun Us, Inc.
Immunology · 287d
Cleared Oct 15, 2008
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674
The Binding Site, Ltd.
Immunology · 120d
Cleared Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775
Phadia US, Inc.
Immunology · 83d
Cleared Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
K070083
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
K062708
Inova Diagnostics, Inc.
Immunology · 93d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGG II
K052142
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGA II
K052143
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Aug 02, 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357
Sweden Diagnostics (Germany) GmbH
Immunology · 74d
Cleared Jul 16, 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354
Sweden Diagnostics (Germany) GmbH
Immunology · 57d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797
Diamedix Corp.
Immunology · 38d
Cleared Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393
Zeus Scientific, Inc.
Immunology · 35d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250
Zeus Scientific, Inc.
Immunology · 45d
Cleared Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204
Zeus Scientific, Inc.
Immunology · 64d

About Product Code MST - Regulatory Context