MVM — Autoantibodies, Endomysial(Tissue Transglutaminase) Class II
FDA Device Classification
Classification Details
- Product Code
- MVM
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K200230 | inova diagnostics | Aptiva Celiac Disease IgG Reagent | August 26, 2021 |
| K193604 | inova diagnostics | Aptiva Celiac Disease IgA Reagent | June 16, 2021 |
| K181871 | phadia | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG | March 1, 2019 |
| K183313 | euroimmun us | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transg | February 28, 2019 |
| K140691 | sqi diagnostics systems | IG_PLEX CELIAC DGP PANEL | November 6, 2014 |
| K123713 | immco diagnostics | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | October 25, 2013 |
| K130053 | bio-rad laboratories | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CE | September 19, 2013 |
| K102490 | sqi diagnostics systems | IGX PLEX CELIAC QUALITATIVE ASSAY | June 2, 2011 |
| K101644 | inova diagnostics | QUANTA FLASH H-TTG IGG | March 23, 2011 |
| K102964 | grifols usa | EU-TTG IGA AND EU-TTG IGG | March 7, 2011 |
| K094060 | inova diagnostics | QUANTA FLASH H-TTG IGA | October 13, 2010 |
| K091520 | immco diagnostics | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | March 10, 2010 |
| K073145 | inova diagnostics | QUANTA LITE H-TTG SCREEN | February 12, 2008 |
| K072632 | inova diagnostics | QUANTA PLEX CELIAC IGG PROFILE | February 11, 2008 |
| K072967 | inova diagnostics | QUANTA LITE F-ACTIN IGA ELISA | January 28, 2008 |
| K071692 | theratest laboratories | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | November 5, 2007 |
| K063818 | inova diagnostics | QUANTA PLEX CELIAC IGA PROFILE | June 20, 2007 |
| K062787 | phadia us | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 | December 29, 2006 |
| K062583 | phadia us | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 | December 26, 2006 |
| K061408 | euroimmun us | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | October 5, 2006 |