Product code MVM
- Device name
- Autoantibodies, Endomysial(Tissue Transglutaminase)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- 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 |
|---|---|---|---|
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021-08-26 |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | 2021-06-16 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Phadia AB | 2019-03-01 |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. | 2019-02-28 |
| K140691 | IG_PLEX CELIAC DGP PANEL | Sqi Diagnostics Systems, Inc. | 2014-11-06 |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2013-10-25 |
| K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| K102490 | IGX PLEX CELIAC QUALITATIVE ASSAY | Sqi Diagnostics Systems | 2011-06-02 |
| K101644 | QUANTA FLASH H-TTG IGG | Inova Diagnostics, Inc. | 2011-03-23 |
| K102964 | EU-TTG IGA AND EU-TTG IGG | Grifols USA, Inc. | 2011-03-07 |
| K094060 | QUANTA FLASH H-TTG IGA | Inova Diagnostics, Inc. | 2010-10-13 |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-03-10 |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | 2008-02-12 |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | 2008-02-11 |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | 2008-01-28 |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | Theratest Laboratories, Inc. | 2007-11-05 |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | Inova Diagnostics, Inc. | 2007-06-20 |
| K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | 2006-12-29 |
| K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | 2006-12-26 |
| K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | Euroimmun Us, LLC | 2006-10-05 |
| K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | Immco Diagnostics, Inc. | 2006-05-25 |
| K042644 | AESKULISA TTG A AND AESKULISA TTG G | Aesku, Inc. | 2005-06-01 |
| K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | Hycor Biomedical , Ltd. | 2005-03-07 |
| K041173 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| K041174 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 | Sweden Diagnostics (Germany) GmbH | 2004-07-19 |
| K040466 | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS | The Binding Site | 2004-07-16 |
| K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA | Immco Diagnostics, Inc. | 2004-03-05 |
| K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | Hycor Biomedical , Ltd. | 2004-01-20 |
| K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA | Immco Diagnostics, Inc. | 2003-12-24 |
| K011570 | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA | Inova Diagnostics, Inc. | 2001-07-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049016161608 | IFA: Oesophagus (Monkey) IgA | EUROIMMUN Medizinische Labordiagnostika AG | 2025-10-21 |
| 04049016161592 | IFA: Oesophagus (Monkey) IgA | EUROIMMUN Medizinische Labordiagnostika AG | 2025-10-21 |
| 00845533002011 | Endomysium (Primate esophagus) | ZEUS SCIENTIFIC, INC. | 2025-10-17 |
| 08430793040532 | Aptiva® Celiac Disease IgA Reagent | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 08430793040471 | Aptiva® Celiac Disease IgG Reagent | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 08426950593447 | QUANTA Lite® R h-tTG IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-10-31 |
| 08426950594161 | QUANTA Lite® R h-tTG IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-10-31 |
| 00845714002960 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 00847865011129 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010962 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950594093 | QUANTA Lite® F-Actin IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950601890 | QUANTA Flash® h-tTG IgA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950596158 | QUANTA Lite® h-tTG IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595922 | QUANTA Lite® h-tTG Screen ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594277 | QUANTA Lite® tTG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594130 | QUANTA Lite® h-tTG IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593928 | QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593560 | QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593300 | QUANTA Lite® h-tTG /DGP Screen ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950553687 | NOVA Lite® Monkey Oesophagus IFA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544470 | QUANTA Flash® h-tTG IgA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544463 | QUANTA Lite® R h-tTG IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544159 | QUANTA Flash® h-tTG IgG Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544142 | QUANTA Lite® R h-tTG IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950513988 | NOVA Lite® Monkey Oesophagus IFA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456131 | QUANTA Lite® h-tTG IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454380 | QUANTA Lite® h-tTG IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950557586 | NOVA Lite® Monkey Oesophagus IFA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-30 |
| 08028169204048 | Eu-tTG IgG | EUROSPITAL SPA | 2016-07-04 |
| 08028169204024 | Eu-tTG IgA | EUROSPITAL SPA | 2016-07-01 |