FDA Product Code
FDA Product Code MST — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5750
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | Immco Diagnostics, Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | Aesku Diagnostics | 2013-12-05 | Traditional | PDF ↗ |
| K113377 | GLIADIN IGA AND GLIADIN LGA | Grifols USA, LLC | 2012-12-14 | Traditional | PDF ↗ |
| K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS | Inova Diagnostics, Inc. | 2012-09-20 | Traditional | PDF ↗ |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | Inova Diagnostics, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 | Phadia US, Inc. | 2010-08-13 | Traditional | PDF ↗ |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-02-04 | Traditional | PDF ↗ |
| K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | Euroimmun Us, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | Euroimmun Us, Inc. | 2009-07-28 | Traditional | PDF ↗ |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | The Binding Site, Ltd. | 2008-10-15 | Traditional | PDF ↗ |
| K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | Phadia US, Inc. | 2007-03-14 | Traditional | PDF ↗ |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | Inova Diagnostics, Inc. | 2007-03-12 | Traditional | PDF ↗ |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | Inova Diagnostics, Inc. | 2006-12-13 | Traditional | PDF ↗ |
| K053383 | FIDIS CELIAC | Biomedical Diagnostics (Bmd) SA | 2006-03-29 | Traditional | PDF ↗ |
| K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 | Pharmacia Diagnostics AB | 2006-02-07 | Traditional | PDF ↗ |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | Aesku Diagnostics | 2006-02-07 | Traditional | PDF ↗ |
| K052143 | QUANTA LITE GLIADIN IGA II | Inova Diagnostics, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K052142 | QUANTA LITE GLIADIN IGG II | Inova Diagnostics, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K041002 | FIDIS CELIAC | Biomedical Diagnostics S.A. | 2004-09-24 | Traditional | PDF ↗ |
| K041357 | VARELISA GLIADIN IGG ANTIBODIES | Sweden Diagnostics (Germany) GmbH | 2004-08-02 | Traditional | PDF ↗ |
| K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 | Sweden Diagnostics (Germany) GmbH | 2004-07-16 | Traditional | PDF ↗ |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Diamedix Corp. | 2001-09-28 | Traditional | PDF ↗ |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Diamedix Corp. | 2001-09-28 | Traditional | PDF ↗ |
| K002358 | MDI GLIADIN A TEST | Micro Detect, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 | Traditional | PDF ↗ |
| K002359 | MDI GLIADIN G TEST | Micro Detect, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 | Traditional | PDF ↗ |
| K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR | Zeus Scientific, Inc. | 2000-06-07 | Traditional | PDF ↗ |
| K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-11-12 | Traditional | PDF ↗ |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | Traditional | PDF ↗ |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | Traditional | PDF ↗ |
| K990207 | GLIADIN IGA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K990204 | GLIADIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K973910 | GLIADIN ANTIBODIES ELISA | Genesis Diagnostics , Ltd. | 1999-02-17 | Traditional | PDF ↗ |
| K982533 | UNICAP GLIADIN IGA ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | Traditional | PDF ↗ |
| K982701 | UNICAP GLIADIN IGG ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | Traditional | PDF ↗ |
| K981644 | BINDAZYME ANTIGLIADIN IGG | The Binding Site, Ltd. | 1998-09-03 | Traditional | PDF ↗ |
| K981929 | BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT | The Binding Site, Ltd. | 1998-09-03 | Traditional | PDF ↗ |
| K964986 | QUANTA LITE IGA GLIADIN ELISA | Inova Diagnostics, Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K964985 | QUANTA LITE IGG GLIADIN ELISA | Inova Diagnostics, Inc. | 1997-05-30 | Traditional | PDF ↗ |
| K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | Traditional | PDF ↗ |
| K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | Traditional | PDF ↗ |
Product code MST · Class II · Immunology. Data: openFDA.