Product code MST
- Device name
- Antibodies, Gliadin
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5750
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | Immco Diagnostics, Inc. | 2017-07-28 |
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | Aesku Diagnostics | 2013-12-05 |
| K113377 | GLIADIN IGA AND GLIADIN LGA | Grifols USA, LLC | 2012-12-14 |
| 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 |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | Inova Diagnostics, Inc. | 2011-10-20 |
| 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 |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-02-04 |
| K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | Euroimmun Us, Inc. | 2009-08-07 |
| K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | Euroimmun Us, Inc. | 2009-07-28 |
| 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 |
| K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | Phadia US, Inc. | 2007-03-14 |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | Inova Diagnostics, Inc. | 2007-03-12 |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | Inova Diagnostics, Inc. | 2006-12-13 |
| K053383 | FIDIS CELIAC | Biomedical Diagnostics (Bmd) SA | 2006-03-29 |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | Aesku Diagnostics | 2006-02-07 |
| K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 | Pharmacia Diagnostics AB | 2006-02-07 |
| K052142 | QUANTA LITE GLIADIN IGG II | Inova Diagnostics, Inc. | 2005-10-04 |
| K052143 | QUANTA LITE GLIADIN IGA II | Inova Diagnostics, Inc. | 2005-10-04 |
| K041002 | FIDIS CELIAC | Biomedical Diagnostics S.A. | 2004-09-24 |
| K041357 | VARELISA GLIADIN IGG ANTIBODIES | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 | Sweden Diagnostics (Germany) GmbH | 2004-07-16 |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Diamedix Corp. | 2001-09-28 |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Diamedix Corp. | 2001-09-28 |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 |
| K002358 | MDI GLIADIN A TEST | Micro Detect, Inc. | 2000-10-19 |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 |
| K002359 | MDI GLIADIN G TEST | Micro Detect, Inc. | 2000-10-19 |
| 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 |
| K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-11-12 |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474033700 | Gliadin IgA ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474033717 | Gliadin IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239033703 | Gliadin IgA ELISA | DRG International Inc | 2023-08-24 |
| 00840239033710 | Gliadin IgG ELISA | DRG International Inc | 2023-08-24 |
| 08430793040471 | Aptiva® Celiac Disease IgG Reagent | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 08430793040532 | Aptiva® Celiac Disease IgA Reagent | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 00847865013000 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2020-01-30 |
| 07333066019925 | ImmunoCAP Gliadin IgG Control High | Phadia AB | 2019-03-29 |
| 07333066019918 | ImmunoCAP Gliadin IgA Control High | Phadia AB | 2019-03-29 |
| 07333066019901 | ImmunoCAP Gliadin IgA/IgG Control Low | Phadia AB | 2019-03-29 |
| 07333066019819 | ImmunoCAP Specific IgA/IgG Sample Diluent | Phadia AB | 2019-03-28 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002960 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 07333066012230 | ImmunoCAP Specific IgA Conjugate | Phadia AB | 2016-09-23 |
| 07333066014807 | EliA GliadinDP IgG Well | Phadia AB | 2016-09-23 |
| 07333066014791 | EliA GliadinDP IgA Well | Phadia AB | 2016-09-23 |
| 07333066014692 | EliA Gliadin IgG Well | Phadia AB | 2016-09-23 |
| 07333066014685 | EliA Gliadin IgA Well | Phadia AB | 2016-09-23 |
| 07333066003757 | ImmunoCAP Antigen AGf98, Gliadin | Phadia AB | 2016-09-23 |
| 00847865013017 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010863 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010856 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010580 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010573 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001250 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950593300 | QUANTA Lite® h-tTG /DGP Screen ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544166 | QUANTA Flash® DGP IgG Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544173 | QUANTA Flash® DGP IgA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |