FDA 510(k) Applications for Medical Device Product Code "MVM"
(Autoantibodies, Endomysial(Tissue Transglutaminase))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K042644 | AESKU, INC | AESKULISA TTG A AND AESKULISA TTG G | 06/01/2005 |
| K130053 | BIO-RAD LABORATORIES, INC. | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | 09/19/2013 |
| K061408 | EUROIMMUN US LLC | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | 10/05/2006 |
| K183313 | Euroimmun US, Inc. | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | 02/28/2019 |
| K102964 | GRIFOLS USA, INC. | EU-TTG IGA AND EU-TTG IGG | 03/07/2011 |
| K043433 | HYCOR BIOMEDICAL LTD. | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | 03/07/2005 |
| K033744 | HYCOR BIOMEDICAL LTD. | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | 01/20/2004 |
| K992878 | IMMCO DIAGNOSTICS, INC. | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST | 10/15/1999 |
| K060157 | IMMCO DIAGNOSTICS, INC. | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | 05/25/2006 |
| K032571 | IMMCO DIAGNOSTICS, INC. | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA | 12/24/2003 |
| K040095 | IMMCO DIAGNOSTICS, INC. | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA | 03/05/2004 |
| K091520 | IMMCO DIAGNOSTICS, INC. | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | 03/10/2010 |
| K123713 | IMMCO DIAGNOSTICS, INC. | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | 10/25/2013 |
| K193604 | Inova Diagnostics, Inc. | Aptiva Celiac Disease IgA Reagent | 06/16/2021 |
| K200230 | Inova Diagnostics, Inc. | Aptiva Celiac Disease IgG Reagent | 08/26/2021 |
| K094060 | INOVA DIAGNOSTICS, INC. | QUANTA FLASH H-TTG IGA | 10/13/2010 |
| K101644 | INOVA DIAGNOSTICS, INC. | QUANTA FLASH H-TTG IGG | 03/23/2011 |
| K984137 | INOVA DIAGNOSTICS, INC. | QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA | 01/28/1999 |
| K072967 | INOVA DIAGNOSTICS, INC. | QUANTA LITE F-ACTIN IGA ELISA | 01/28/2008 |
| K011566 | INOVA DIAGNOSTICS, INC. | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA | 07/09/2001 |
| K011570 | INOVA DIAGNOSTICS, INC. | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA | 07/09/2001 |
| K073145 | INOVA DIAGNOSTICS, INC. | QUANTA LITE H-TTG SCREEN | 02/12/2008 |
| K982366 | INOVA DIAGNOSTICS, INC. | QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA | 08/27/1998 |
| K063818 | INOVA DIAGNOSTICS, INC. | QUANTA PLEX CELIAC IGA PROFILE | 06/20/2007 |
| K072632 | INOVA DIAGNOSTICS, INC. | QUANTA PLEX CELIAC IGG PROFILE | 02/11/2008 |
| K993034 | MEDICA, INC. | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD | 11/01/1999 |
| K181871 | Phadia AB | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | 03/01/2019 |
| K062787 | PHADIA US INC. | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 | 12/29/2006 |
| K062583 | PHADIA US INC. | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 | 12/26/2006 |
| K994379 | SCIMEDX CORP. | EU-TTG IGA ELISA | 02/18/2000 |
| K010625 | SCIMEDX CORP. | EUROSPITAL EU-TTG IGA UMANA | 04/24/2001 |
| K002107 | SCIMEDX CORP. | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | 08/04/2000 |
| K102490 | SQI DIAGNOSTICS SYSTEMS | IGX PLEX CELIAC QUALITATIVE ASSAY | 06/02/2011 |
| K140691 | SQI DIAGNOSTICS SYSTEMS INC. | IG_PLEX CELIAC DGP PANEL | 11/06/2014 |
| K041173 | SWEDEN DIAGNOSTICS (GERMANY) GMBH | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 | 08/02/2004 |
| K041174 | SWEDEN DIAGNOSTICS (GERMANY) GMBH | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 | 07/19/2004 |
| K040466 | THE BINDING SITE | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS | 07/16/2004 |
| K993612 | THE BINDING SITE, LTD. | BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA | 12/21/1999 |
| K981209 | THE BINDING SITE, LTD. | MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS | 10/22/1998 |
| K071692 | THERATEST LABORATORIES, INC. | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | 11/05/2007 |
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