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 Sweden Diagnostics (Germany) GmbH.

40
Total
40
Cleared
156d
Avg days
1998
Since
40 devices
25–40 of 40
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 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