Panels › Immunology › Product code MST · Class 2
Antibodies, Gliadin
Regulation 866.5750
0510(k)s in 12 months (42 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MST
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2017 | K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA Immco Diagnostics, Inc. | MST |
| Dec 5, 2013 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK Aesku Diagnostics, DE | MST |
| Dec 14, 2012 | K113377 | GLIADIN IGA AND GLIADIN LGA Grifols USA, LLC | MST |
| Sep 20, 2012 | K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS Inova Diagnostics, Inc. | MST |
| Oct 20, 2011 | K111414 | QUANTA FLASH (TM) DGP SCREEN Inova Diagnostics, Inc. | MST |
| Aug 13, 2010 | K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 Phadia US, Inc. | MST |
| Feb 4, 2010 | K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MST |
| Aug 7, 2009 | K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) Euroimmun Us, Inc. | MST |
| Jul 28, 2009 | K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) Euroimmun Us, Inc. | MST |
| Oct 15, 2008 | K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) The Binding Site, Ltd. | MST |
| Mar 14, 2007 | K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL Phadia US, Inc. | MST |
| Mar 12, 2007 | K070083 | QUANTA LITE H-TTG/DGP SCREEN Inova Diagnostics, Inc. | MST |
| Dec 13, 2006 | K062708 | QUANTA LITE CELIAC DGP SCREEN Inova Diagnostics, Inc. | MST |
| Mar 29, 2006 | K053383 | FIDIS CELIAC Biomedical Diagnostics (Bmd) SA, FR | MST |
| Feb 7, 2006 | K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 Pharmacia Diagnostics AB | MST |
| Feb 7, 2006 | K052439 | AESKULISA GLIA A AND AESKULISA GLIA G Aesku Diagnostics | MST |
| Oct 4, 2005 | K052143 | QUANTA LITE GLIADIN IGA II Inova Diagnostics, Inc. | MST |
| Oct 4, 2005 | K052142 | QUANTA LITE GLIADIN IGG II Inova Diagnostics, Inc. | MST |
| Sep 24, 2004 | K041002 | FIDIS CELIAC Biomedical Diagnostics S.A., FR | MST |
| Aug 2, 2004 | K041357 | VARELISA GLIADIN IGG ANTIBODIES Sweden Diagnostics (Germany) GmbH, DE | MST |
| Jul 16, 2004 | K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 Sweden Diagnostics (Germany) GmbH, DE | MST |
| Sep 28, 2001 | K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM Diamedix Corp. | MST |
| Sep 28, 2001 | K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM Diamedix Corp. | MST |
| Oct 19, 2000 | K002359 | MDI GLIADIN G TEST Micro Detect, Inc. | MST |
| Oct 19, 2000 | K002358 | MDI GLIADIN A TEST Micro Detect, Inc. | MST |
| Oct 19, 2000 | K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. | MST |
| Oct 19, 2000 | K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. | MST |
| Jun 7, 2000 | K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR Zeus Scientific, Inc. | MST |
| Nov 12, 1999 | K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. | MST |
| Nov 12, 1999 | K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA Cogent Diagnotics , Ltd., GB | MST |
| Nov 12, 1999 | K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA Cogent Diagnotics , Ltd., GB | MST |
| Mar 26, 1999 | K990207 | GLIADIN IGA ELISA TEST SYSTEM Zeus Scientific, Inc. | MST |
| Mar 26, 1999 | K990204 | GLIADIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | MST |
| Feb 17, 1999 | K973910 | GLIADIN ANTIBODIES ELISA Genesis Diagnostics , Ltd., GB | MST |
| Oct 22, 1998 | K982701 | UNICAP GLIADIN IGG ASSAY Pharmacia & Upjohn Co. | MST |
| Oct 22, 1998 | K982533 | UNICAP GLIADIN IGA ASSAY Pharmacia & Upjohn Co. | MST |
| Sep 3, 1998 | K981929 | BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT The Binding Site, Ltd. | MST |
| Sep 3, 1998 | K981644 | BINDAZYME ANTIGLIADIN IGG The Binding Site, Ltd. | MST |
| Jun 2, 1997 | K964986 | QUANTA LITE IGA GLIADIN ELISA Inova Diagnostics, Inc. | MST |
| May 30, 1997 | K964985 | QUANTA LITE IGG GLIADIN ELISA Inova Diagnostics, Inc. | MST |
| May 30, 1997 | K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. | MST |
| May 30, 1997 | K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. | MST |
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