Product code MST— Immunology
FIDIS CELIAC
- Classification name
- Antibodies, Gliadin
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Total cleared
- 42
- First cleared
- Most recent
Market context for product code MST
FDA has cleared devices under product code MST between 1997 and 2017, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2001
- 2000
- 1999
- 1998
Top applicants under product code MST
Recent clearances under product code MST
- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
- K113377 — GLIADIN IGA AND GLIADIN LGA
- K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
- K111414 — QUANTA FLASH (TM) DGP SCREEN
- K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
- K083053 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
- K083052 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
- K063775 — ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
- K070083 — QUANTA LITE H-TTG/DGP SCREEN
- K062708 — QUANTA LITE CELIAC DGP SCREEN
- K053383 — FIDIS CELIAC
- K052439 — AESKULISA GLIA A AND AESKULISA GLIA G
- K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
- K052142 — QUANTA LITE GLIADIN IGG II
- K052143 — QUANTA LITE GLIADIN IGA II
- K041002 — FIDIS CELIAC
- K041357 — VARELISA GLIADIN IGG ANTIBODIES
- K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
- K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
- K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
- K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
- K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
- K002358 — MDI GLIADIN A TEST
- K002359 — MDI GLIADIN G TEST
- K001393 — THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
- K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA
- K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA
- K993250 — THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
- K990204 — GLIADIN IGG ELISA TEST SYSTEM
- K990207 — GLIADIN IGA ELISA TEST SYSTEM
- K973910 — GLIADIN ANTIBODIES ELISA
- K982533 — UNICAP GLIADIN IGA ASSAY
- K982701 — UNICAP GLIADIN IGG ASSAY
- K981644 — BINDAZYME ANTIGLIADIN IGG
- K981929 — BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
- K964986 — QUANTA LITE IGA GLIADIN ELISA
- K964341 — IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
- K964344 — IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
- K964985 — QUANTA LITE IGG GLIADIN ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.