MST · Class II · 21 CFR 866.5750

FDA Product Code MST: Antibodies, Gliadin

Leading manufacturers include Inova Diagnostics, Inc., Zeus Scientific, Inc. and Immco Diagnostics, Inc..

42
Total
42
Cleared
141d
Avg days
1997
Since
42 devices
25–42 of 42
Cleared Oct 19, 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189
Scimedx Corp.
Immunology · 92d
Cleared Oct 19, 2000
MDI GLIADIN A TEST
K002358
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
MDI GLIADIN G TEST
K002359
Micro Detect, Inc.
Immunology · 78d
Cleared Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393
Zeus Scientific, Inc.
Immunology · 35d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250
Zeus Scientific, Inc.
Immunology · 45d
Cleared Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207
Zeus Scientific, Inc.
Immunology · 64d
Cleared Feb 17, 1999
GLIADIN ANTIBODIES ELISA
K973910
Genesis Diagnostics , Ltd.
Immunology · 491d
Cleared Oct 22, 1998
UNICAP GLIADIN IGA ASSAY
K982533
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
UNICAP GLIADIN IGG ASSAY
K982701
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
K981644
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929
The Binding Site, Ltd.
Immunology · 118d
Cleared Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
K964986
Inova Diagnostics, Inc.
Immunology · 171d
Cleared May 30, 1997
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
K964341
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
K964985
Inova Diagnostics, Inc.
Immunology · 168d