MVM — Autoantibodies, Endomysial(Tissue Transglutaminase) Class II
FDA product code MVM covers "Autoantibodies, Endomysial(Tissue Transglutaminase)", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |