FDA Product Code
FDA Product Code MVM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | 2021-06-16 | Traditional | PDF ↗ |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Phadia AB | 2019-03-01 | Traditional | PDF ↗ |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. | 2019-02-28 | Traditional | PDF ↗ |
| K140691 | IG_PLEX CELIAC DGP PANEL | Sqi Diagnostics Systems, Inc. | 2014-11-06 | Traditional | PDF ↗ |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2013-10-25 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K102490 | IGX PLEX CELIAC QUALITATIVE ASSAY | Sqi Diagnostics Systems | 2011-06-02 | Traditional | PDF ↗ |
| K101644 | QUANTA FLASH H-TTG IGG | Inova Diagnostics, Inc. | 2011-03-23 | Traditional | PDF ↗ |
| K102964 | EU-TTG IGA AND EU-TTG IGG | Grifols USA, Inc. | 2011-03-07 | Traditional | PDF ↗ |
| K094060 | QUANTA FLASH H-TTG IGA | Inova Diagnostics, Inc. | 2010-10-13 | Traditional | PDF ↗ |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | 2008-02-12 | Traditional | PDF ↗ |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | 2008-01-28 | Traditional | PDF ↗ |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | Theratest Laboratories, Inc. | 2007-11-05 | Traditional | PDF ↗ |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | Inova Diagnostics, Inc. | 2007-06-20 | Traditional | PDF ↗ |
| K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | 2006-12-29 | Traditional | PDF ↗ |
| K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | 2006-12-26 | Traditional | PDF ↗ |
| K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | Euroimmun Us, LLC | 2006-10-05 | Traditional | PDF ↗ |
| K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | Immco Diagnostics, Inc. | 2006-05-25 | Traditional | PDF ↗ |
| K042644 | AESKULISA TTG A AND AESKULISA TTG G | Aesku, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | Hycor Biomedical , Ltd. | 2005-03-07 | Traditional | PDF ↗ |
| K041173 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 | Sweden Diagnostics (Germany) GmbH | 2004-08-02 | Traditional | PDF ↗ |
| K041174 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 | Sweden Diagnostics (Germany) GmbH | 2004-07-19 | Traditional | PDF ↗ |
| K040466 | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS | The Binding Site | 2004-07-16 | Traditional | PDF ↗ |
| K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA | Immco Diagnostics, Inc. | 2004-03-05 | Traditional | PDF ↗ |
| K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | Hycor Biomedical , Ltd. | 2004-01-20 | Traditional | PDF ↗ |
| K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA | Immco Diagnostics, Inc. | 2003-12-24 | Traditional | PDF ↗ |
| K011566 | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA | Inova Diagnostics, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K011570 | QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA | Inova Diagnostics, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K010625 | EUROSPITAL EU-TTG IGA UMANA | Scimedx Corp. | 2001-04-24 | Traditional | PDF ↗ |
| K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | Scimedx Corp. | 2000-08-04 | Traditional | PDF ↗ |
| K994379 | EU-TTG IGA ELISA | Scimedx Corp. | 2000-02-18 | Traditional | PDF ↗ |
| K993612 | BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA | The Binding Site, Ltd. | 1999-12-21 | Traditional | PDF ↗ |
| K993034 | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD | Medica, Inc. | 1999-11-01 | Traditional | PDF ↗ |
| K992878 | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST | Immco Diagnostics, Inc. | 1999-10-15 | Traditional | PDF ↗ |
| K984137 | QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA | Inova Diagnostics, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K981209 | MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | 1998-10-22 | Traditional | PDF ↗ |
| K982366 | QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA | Inova Diagnostics, Inc. | 1998-08-27 | Traditional | PDF ↗ |
Product code MVM · Class II · Immunology. Data: openFDA.