Panels › Immunology › Product code MVM · Class 2
Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation 866.5660
0510(k)s in 12 months (40 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MVM
| Company | 510(k)s | Recalls |
|---|---|---|
| Inova Diagnostics, Inc. | 12 | 0 |
| Immco Diagnostics, Inc. | 6 | 0 |
| The Binding Site | 3 | 0 |
| Scimedx Corp. | 3 | 0 |
| Euroimmun Us, Inc. | 2 | 0 |
| Hycor Biomedical , Ltd. | 2 | 0 |
| Phadia US, Inc. | 2 | 0 |
| Sqi Diagnostics Systems | 2 | 0 |
| Sweden Diagnostics (Germany) GmbH | 2 | 0 |
| Aesku, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2021 | K200230 | Aptiva Celiac Disease IgG Reagent Inova Diagnostics, Inc. | MVM |
| Jun 16, 2021 | K193604 | Aptiva Celiac Disease IgA Reagent Inova Diagnostics, Inc. | MVM |
| Mar 1, 2019 | K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay Phadia AB, SE | MVM |
| Feb 28, 2019 | K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) Euroimmun Us, Inc. | MVM |
| Nov 6, 2014 | K140691 | IG_PLEX CELIAC DGP PANEL Sqi Diagnostics Systems, Inc., CA | MVM |
| Oct 25, 2013 | K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MVM |
| Sep 19, 2013 | 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. | MVM |
| Jun 2, 2011 | K102490 | IGX PLEX CELIAC QUALITATIVE ASSAY Sqi Diagnostics Systems, CA | MVM |
| Mar 23, 2011 | K101644 | QUANTA FLASH H-TTG IGG Inova Diagnostics, Inc. | MVM |
| Mar 7, 2011 | K102964 | EU-TTG IGA AND EU-TTG IGG Grifols USA, Inc. | MVM |
| Oct 13, 2010 | K094060 | QUANTA FLASH H-TTG IGA Inova Diagnostics, Inc. | MVM |
| Mar 10, 2010 | K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. | MVM |
| Feb 12, 2008 | K073145 | QUANTA LITE H-TTG SCREEN Inova Diagnostics, Inc. | MVM |
| Feb 11, 2008 | K072632 | QUANTA PLEX CELIAC IGG PROFILE Inova Diagnostics, Inc. | MVM |
| Jan 28, 2008 | K072967 | QUANTA LITE F-ACTIN IGA ELISA Inova Diagnostics, Inc. | MVM |
| Nov 5, 2007 | K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS Theratest Laboratories, Inc. | MVM |
| Jun 20, 2007 | K063818 | QUANTA PLEX CELIAC IGA PROFILE Inova Diagnostics, Inc. | MVM |
| Dec 29, 2006 | K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. | MVM |
| Dec 26, 2006 | K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. | MVM |
| Oct 5, 2006 | K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT Euroimmun Us, LLC | MVM |
| May 25, 2006 | K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA Immco Diagnostics, Inc. | MVM |
| Jun 1, 2005 | K042644 | AESKULISA TTG A AND AESKULISA TTG G Aesku, Inc. | MVM |
| Mar 7, 2005 | K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA Hycor Biomedical , Ltd., GB | MVM |
| Aug 2, 2004 | K041173 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 Sweden Diagnostics (Germany) GmbH, DE | MVM |
| Jul 19, 2004 | K041174 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 Sweden Diagnostics (Germany) GmbH, DE | MVM |
| Jul 16, 2004 | K040466 | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS The Binding Site | MVM |
| Mar 5, 2004 | K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA Immco Diagnostics, Inc. | MVM |
| Jan 20, 2004 | K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA Hycor Biomedical , Ltd., GB | MVM |
| Dec 24, 2003 | K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA Immco Diagnostics, Inc. | MVM |
| Jul 9, 2001 | K011570 | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA Inova Diagnostics, Inc. | MVM |
| Jul 9, 2001 | K011566 | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA Inova Diagnostics, Inc. | MVM |
| Apr 24, 2001 | K010625 | EUROSPITAL EU-TTG IGA UMANA Scimedx Corp. | MVM |
| Aug 4, 2000 | K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. Scimedx Corp. | MVM |
| Feb 18, 2000 | K994379 | EU-TTG IGA ELISA Scimedx Corp. | MVM |
| Dec 21, 1999 | K993612 | BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA The Binding Site, Ltd. | MVM |
| Nov 1, 1999 | K993034 | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD Medica, Inc. | MVM |
| Oct 15, 1999 | K992878 | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST Immco Diagnostics, Inc. | MVM |
| Jan 28, 1999 | K984137 | QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA Inova Diagnostics, Inc. | MVM |
| Oct 22, 1998 | K981209 | MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS The Binding Site, Ltd. | MVM |
| Aug 27, 1998 | K982366 | QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA Inova Diagnostics, Inc. | MVM |
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