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 Phadia US, Inc..

40
Total
40
Cleared
156d
Avg days
1998
Since

FDA 510(k) Cleared Autoantibodies, Endomysial(tissue Transglutaminase) Devices (Product Code MVM)

40 devices
1–24 of 40
Cleared Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
K200230
Inova Diagnostics, Inc.
Immunology · 574d
Cleared Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
K193604
Inova Diagnostics, Inc.
Immunology · 541d
Cleared Mar 01, 2019
EliA Celikey IgG Immunoassay
K181871
Phadia AB
Immunology · 232d
Cleared Feb 28, 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313
Euroimmun Us, Inc.
Immunology · 91d
Cleared Nov 06, 2014
IG_PLEX CELIAC DGP PANEL
K140691
Sqi Diagnostics Systems, Inc.
Immunology · 232d
Cleared Oct 25, 2013
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713
Immco Diagnostics, Inc.
Immunology · 325d
Cleared Sep 19, 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053
Bio-Rad Laboratories, Inc.
Immunology · 247d
Cleared Mar 23, 2011
QUANTA FLASH H-TTG IGG
K101644
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Oct 13, 2010
QUANTA FLASH H-TTG IGA
K094060
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Mar 10, 2010
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520
Immco Diagnostics, Inc.
Immunology · 292d
Cleared Feb 12, 2008
QUANTA LITE H-TTG SCREEN
K073145
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Feb 11, 2008
QUANTA PLEX CELIAC IGG PROFILE
K072632
Inova Diagnostics, Inc.
Immunology · 146d
Cleared Jan 28, 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Nov 05, 2007
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K071692
Theratest Laboratories, Inc.
Immunology · 138d
Cleared Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
K063818
Inova Diagnostics, Inc.
Immunology · 180d
Cleared Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787
Phadia US, Inc.
Immunology · 102d
Cleared Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583
Phadia US, Inc.
Immunology · 116d
Cleared May 25, 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157
Immco Diagnostics, Inc.
Immunology · 125d
Cleared Jun 01, 2005
AESKULISA TTG A AND AESKULISA TTG G
K042644
Aesku, Inc.
Immunology · 247d
Cleared Mar 07, 2005
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
K043433
Hycor Biomedical , Ltd.
Immunology · 84d
Cleared Aug 02, 2004
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
K041173
Sweden Diagnostics (Germany) GmbH
Immunology · 89d
Cleared Jul 19, 2004
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
K041174
Sweden Diagnostics (Germany) GmbH
Immunology · 75d
Cleared Mar 05, 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095
Immco Diagnostics, Inc.
Immunology · 45d
Cleared Dec 24, 2003
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571
Immco Diagnostics, Inc.
Immunology · 126d

About Product Code MVM - Regulatory Context