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 The Binding Site, Ltd..

40
Total
40
Cleared
156d
Avg days
1998
Since
Stable submission activity - 0 submissions in the last 2 years

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 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 Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
K063818
Inova Diagnostics, Inc.
Immunology · 180d
Cleared May 25, 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157
Immco Diagnostics, Inc.
Immunology · 125d
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
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 Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612
The Binding Site, Ltd.
Immunology · 57d
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

About Product Code MVM - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code MVM since 1998, with 40 receiving FDA clearance (average review time: 156 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.