MVM · Class II · 21 CFR 866.5660

FDA Product Code MVM: Autoantibodies, Endomysial(tissue Transglutaminase)

Leading manufacturers include Inova Diagnostics, Inc., Immco Diagnostics, Inc. and Scimedx Corp..

40
Total
40
Cleared
156d
Avg days
1998
Since
40 devices
25–40 of 40
Cleared Jul 19, 2004
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
K041174
Sweden Diagnostics (Germany) GmbH
Immunology · 75d
Cleared Jul 16, 2004
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
K040466
The Binding Site
Immunology · 144d
Cleared Mar 05, 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095
Immco Diagnostics, Inc.
Immunology · 45d
Cleared Jan 20, 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K033744
Hycor Biomedical , Ltd.
Immunology · 50d
Cleared Dec 24, 2003
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571
Immco Diagnostics, Inc.
Immunology · 126d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
K010625
Scimedx Corp.
Immunology · 53d
Cleared Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
K002107
Scimedx Corp.
Immunology · 23d
Cleared Feb 18, 2000
EU-TTG IGA ELISA
K994379
Scimedx Corp.
Immunology · 53d
Cleared Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612
The Binding Site, Ltd.
Immunology · 57d
Cleared Nov 01, 1999
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD
K993034
Medica, Inc.
Immunology · 53d
Cleared Oct 15, 1999
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
K992878
Immco Diagnostics, Inc.
Immunology · 50d
Cleared Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
K984137
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209
The Binding Site, Ltd.
Immunology · 203d
Cleared Aug 27, 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
K982366
Inova Diagnostics, Inc.
Immunology · 51d