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MST — Antibodies, Gliadin Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K163177immco diagnosticsImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG AntiJuly 28, 2017
K132082aesku diagnosticsAESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKDecember 5, 2013
K113377grifols usaGLIADIN IGA AND GLIADIN LGADecember 14, 2012
K113863inova diagnosticsQUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUSeptember 20, 2012
K111414inova diagnosticsQUANTA FLASH (TM) DGP SCREENOctober 20, 2011
K093459phadia usELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5August 13, 2010
K091522immco diagnosticsIMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISAFebruary 4, 2010
K083053euroimmun usEUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)August 7, 2009
K083052euroimmun usEUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)July 28, 2009
K081674binding siteBINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MOctober 15, 2008
K063775phadia usELIA GLIADIN IGA, IGG AND CELIAC CONTROLMarch 14, 2007
K070083inova diagnosticsQUANTA LITE H-TTG/DGP SCREENMarch 12, 2007
K062708inova diagnosticsQUANTA LITE CELIAC DGP SCREENDecember 13, 2006
K053383biomedical diagnostics (bmd)FIDIS CELIACMarch 29, 2006
K052439aesku diagnosticsAESKULISA GLIA A AND AESKULISA GLIA GFebruary 7, 2006
K052793pharmacia diagnosticsIMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, February 7, 2006
K052142inova diagnosticsQUANTA LITE GLIADIN IGG IIOctober 4, 2005
K052143inova diagnosticsQUANTA LITE GLIADIN IGA IIOctober 4, 2005
K041002biomedical diagnosticsFIDIS CELIACSeptember 24, 2004
K041357sweden diagnostics (germany)VARELISA GLIADIN IGG ANTIBODIESAugust 2, 2004