MST — Antibodies, Gliadin Class II
FDA product code MST covers "Antibodies, Gliadin", a Class II medical device regulated under 21 CFR 866.5750. 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
- MST
- Device Class
- Class II
- Regulation Number
- 866.5750
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163177 | immco diagnostics | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Anti | July 28, 2017 |
| K132082 | aesku diagnostics | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | December 5, 2013 |
| K113377 | grifols usa | GLIADIN IGA AND GLIADIN LGA | December 14, 2012 |
| K113863 | inova diagnostics | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QU | September 20, 2012 |
| K111414 | inova diagnostics | QUANTA FLASH (TM) DGP SCREEN | October 20, 2011 |
| K093459 | phadia us | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5 | August 13, 2010 |
| K091522 | immco diagnostics | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | February 4, 2010 |
| K083053 | euroimmun us | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | August 7, 2009 |
| K083052 | euroimmun us | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | July 28, 2009 |
| K081674 | binding site | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (M | October 15, 2008 |
| K063775 | phadia us | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | March 14, 2007 |
| K070083 | inova diagnostics | QUANTA LITE H-TTG/DGP SCREEN | March 12, 2007 |
| K062708 | inova diagnostics | QUANTA LITE CELIAC DGP SCREEN | December 13, 2006 |
| K053383 | biomedical diagnostics (bmd) | FIDIS CELIAC | March 29, 2006 |
| K052439 | aesku diagnostics | AESKULISA GLIA A AND AESKULISA GLIA G | February 7, 2006 |
| K052793 | pharmacia diagnostics | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, | February 7, 2006 |
| K052142 | inova diagnostics | QUANTA LITE GLIADIN IGG II | October 4, 2005 |
| K052143 | inova diagnostics | QUANTA LITE GLIADIN IGA II | October 4, 2005 |
| K041002 | biomedical diagnostics | FIDIS CELIAC | September 24, 2004 |
| K041357 | sweden diagnostics (germany) | VARELISA GLIADIN IGG ANTIBODIES | August 2, 2004 |