Atlas FDA

MST

42 FDA 510(k) clearances · Product code

114 daysmedian time to decision
280 days90th percentile
42clearances measured

FDA profile

Official device name
Antibodies, Gliadin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5750
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA (K163177)Immco Diagnostics, Inc.2017-07-28
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (K132082)Aesku Diagnostics2013-12-05
GLIADIN IGA AND GLIADIN LGA (K113377)Grifols USA, LLC2012-12-14
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS (K113863)Inova Diagnostics, Inc.2012-09-20
QUANTA FLASH (TM) DGP SCREEN (K111414)Inova Diagnostics, Inc.2011-10-20
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 (K093459)Phadia US, Inc.2010-08-13
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (K091522)Immco Diagnostics, Inc.2010-02-04
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (K083053)Euroimmun Us, Inc.2009-08-07
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (K083052)Euroimmun Us, Inc.2009-07-28
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) (K081674)The Binding Site, Ltd.2008-10-15
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (K063775)Phadia US, Inc.2007-03-14
QUANTA LITE H-TTG/DGP SCREEN (K070083)Inova Diagnostics, Inc.2007-03-12
QUANTA LITE CELIAC DGP SCREEN (K062708)Inova Diagnostics, Inc.2006-12-13
FIDIS CELIAC (K053383)Biomedical Diagnostics (Bmd) SA2006-03-29
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 (K052793)Pharmacia Diagnostics AB2006-02-07
AESKULISA GLIA A AND AESKULISA GLIA G (K052439)Aesku Diagnostics2006-02-07
QUANTA LITE GLIADIN IGA II (K052143)Inova Diagnostics, Inc.2005-10-04
QUANTA LITE GLIADIN IGG II (K052142)Inova Diagnostics, Inc.2005-10-04
FIDIS CELIAC (K041002)Biomedical Diagnostics S.A.2004-09-24
VARELISA GLIADIN IGG ANTIBODIES (K041357)Sweden Diagnostics (Germany) GmbH2004-08-02
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (K041354)Sweden Diagnostics (Germany) GmbH2004-07-16
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (K012797)Diamedix Corp.2001-09-28
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (K012795)Diamedix Corp.2001-09-28
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (K002169)Scimedx Corp.2000-10-19
MDI GLIADIN A TEST (K002358)Micro Detect, Inc.2000-10-19
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (K002189)Scimedx Corp.2000-10-19
MDI GLIADIN G TEST (K002359)Micro Detect, Inc.2000-10-19
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR (K001393)Zeus Scientific, Inc.2000-06-07
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. (K993250)Zeus Scientific, Inc.1999-11-12
AUTOSTAT II ANTI-GLIADIN IGG ELISA (K993087)Cogent Diagnotics , Ltd.1999-11-12
AUTOSTAT II ANTI-GLIADIN IGA ELISA (K993086)Cogent Diagnotics , Ltd.1999-11-12
GLIADIN IGG ELISA TEST SYSTEM (K990204)Zeus Scientific, Inc.1999-03-26
GLIADIN IGA ELISA TEST SYSTEM (K990207)Zeus Scientific, Inc.1999-03-26
GLIADIN ANTIBODIES ELISA (K973910)Genesis Diagnostics , Ltd.1999-02-17
UNICAP GLIADIN IGA ASSAY (K982533)Pharmacia & Upjohn Co.1998-10-22
UNICAP GLIADIN IGG ASSAY (K982701)Pharmacia & Upjohn Co.1998-10-22
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT (K981929)The Binding Site, Ltd.1998-09-03
BINDAZYME ANTIGLIADIN IGG (K981644)The Binding Site, Ltd.1998-09-03
QUANTA LITE IGA GLIADIN ELISA (K964986)Inova Diagnostics, Inc.1997-06-02
QUANTA LITE IGG GLIADIN ELISA (K964985)Inova Diagnostics, Inc.1997-05-30
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT (K964341)Immco Diagnostics, Inc.1997-05-30
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT (K964344)Immco Diagnostics, Inc.1997-05-30

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