Atlas FDA

MVM

40 FDA 510(k) clearances · Product code

125 daysmedian time to decision
292 days90th percentile
40clearances measured

FDA profile

Official device name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Medical specialty
Immunology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Aptiva Celiac Disease IgG Reagent (K200230)Inova Diagnostics, Inc.2021-08-26
Aptiva Celiac Disease IgA Reagent (K193604)Inova Diagnostics, Inc.2021-06-16
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (K181871)Phadia AB2019-03-01
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) (K183313)Euroimmun Us, Inc.2019-02-28
IG_PLEX CELIAC DGP PANEL (K140691)Sqi Diagnostics Systems, Inc.2014-11-06
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (K123713)Immco Diagnostics, Inc.2013-10-25
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.2013-09-19
IGX PLEX CELIAC QUALITATIVE ASSAY (K102490)Sqi Diagnostics Systems2011-06-02
QUANTA FLASH H-TTG IGG (K101644)Inova Diagnostics, Inc.2011-03-23
EU-TTG IGA AND EU-TTG IGG (K102964)Grifols USA, Inc.2011-03-07
QUANTA FLASH H-TTG IGA (K094060)Inova Diagnostics, Inc.2010-10-13
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA (K091520)Immco Diagnostics, Inc.2010-03-10
QUANTA LITE H-TTG SCREEN (K073145)Inova Diagnostics, Inc.2008-02-12
QUANTA PLEX CELIAC IGG PROFILE (K072632)Inova Diagnostics, Inc.2008-02-11
QUANTA LITE F-ACTIN IGA ELISA (K072967)Inova Diagnostics, Inc.2008-01-28
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS (K071692)Theratest Laboratories, Inc.2007-11-05
QUANTA PLEX CELIAC IGA PROFILE (K063818)Inova Diagnostics, Inc.2007-06-20
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062787)Phadia US, Inc.2006-12-29
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062583)Phadia US, Inc.2006-12-26
EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT (K061408)Euroimmun Us, LLC2006-10-05
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA (K060157)Immco Diagnostics, Inc.2006-05-25
AESKULISA TTG A AND AESKULISA TTG G (K042644)Aesku, Inc.2005-06-01
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA (K043433)Hycor Biomedical , Ltd.2005-03-07
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (K041173)Sweden Diagnostics (Germany) GmbH2004-08-02
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (K041174)Sweden Diagnostics (Germany) GmbH2004-07-19
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS (K040466)The Binding Site2004-07-16
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA (K040095)Immco Diagnostics, Inc.2004-03-05
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA (K033744)Hycor Biomedical , Ltd.2004-01-20
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA (K032571)Immco Diagnostics, Inc.2003-12-24
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA (K011566)Inova Diagnostics, Inc.2001-07-09
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA (K011570)Inova Diagnostics, Inc.2001-07-09
EUROSPITAL EU-TTG IGA UMANA (K010625)Scimedx Corp.2001-04-24
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. (K002107)Scimedx Corp.2000-08-04
EU-TTG IGA ELISA (K994379)Scimedx Corp.2000-02-18
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA (K993612)The Binding Site, Ltd.1999-12-21
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD (K993034)Medica, Inc.1999-11-01
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST (K992878)Immco Diagnostics, Inc.1999-10-15
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA (K984137)Inova Diagnostics, Inc.1999-01-28
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS (K981209)The Binding Site, Ltd.1998-10-22
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA (K982366)Inova Diagnostics, Inc.1998-08-27

Track MVM automatically

Every clearance here is in the API, with alerts when new ones post.