Autoantibodies, Endomysial(Tissue Transglutaminase)

FDA product code MVM · 39 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5660
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1998-08-27 – 2021-08-26

MVM 2021-08-26

Aptiva Celiac Disease IgG Reagent

Applicant Inova Diagnostics, Inc.

K number K200230

View details →

MVM 2021-06-16

Aptiva Celiac Disease IgA Reagent

Applicant Inova Diagnostics, Inc.

K number K193604

View details →

MVM 2019-03-01

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

Applicant Phadia AB

K number K181871

View details →

MVM 2019-02-28

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

Applicant Euroimmun Us, Inc.

K number K183313

View details →

MVM 2013-10-25

IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K123713

View details →

MVM 2013-09-19

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

Applicant Bio-Rad Laboratories, Inc.

K number K130053

View details →

MVM 2011-06-02

IGX PLEX CELIAC QUALITATIVE ASSAY

Applicant Sqi Diagnostics Systems

K number K102490

View details →

MVM 2011-03-23

QUANTA FLASH H-TTG IGG

Applicant Inova Diagnostics, Inc.

K number K101644

View details →

MVM 2011-03-07

EU-TTG IGA AND EU-TTG IGG

Applicant Grifols USA, Inc.

K number K102964

View details →

MVM 2010-10-13

QUANTA FLASH H-TTG IGA

Applicant Inova Diagnostics, Inc.

K number K094060

View details →

MVM 2010-03-10

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K091520

View details →

MVM 2008-02-12

QUANTA LITE H-TTG SCREEN

Applicant Inova Diagnostics, Inc.

K number K073145

View details →

MVM 2008-02-11

QUANTA PLEX CELIAC IGG PROFILE

Applicant Inova Diagnostics, Inc.

K number K072632

View details →

MVM 2008-01-28

QUANTA LITE F-ACTIN IGA ELISA

Applicant Inova Diagnostics, Inc.

K number K072967

View details →

MVM 2007-11-05

THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

Applicant Theratest Laboratories, Inc.

K number K071692

View details →

MVM 2007-06-20

QUANTA PLEX CELIAC IGA PROFILE

Applicant Inova Diagnostics, Inc.

K number K063818

View details →

MVM 2006-12-29

ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01

Applicant Phadia US, Inc.

K number K062787

View details →

MVM 2006-12-26

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01

Applicant Phadia US, Inc.

K number K062583

View details →

MVM 2006-10-05

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

Applicant Euroimmun Us, LLC

K number K061408

View details →

MVM 2006-05-25

IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA

Applicant Immco Diagnostics, Inc.

K number K060157

View details →

MVM 2005-06-01

AESKULISA TTG A AND AESKULISA TTG G

Applicant Aesku, Inc.

K number K042644

View details →

MVM 2005-03-07

AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

Applicant Hycor Biomedical , Ltd.

K number K043433

View details →

MVM 2004-08-02

CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996

Applicant Sweden Diagnostics (Germany) GmbH

K number K041173

View details →

MVM 2004-07-19

CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

Applicant Sweden Diagnostics (Germany) GmbH

K number K041174

View details →

MVM 2004-07-16

BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS

Applicant The Binding Site

K number K040466

View details →

MVM 2004-03-05

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

Applicant Immco Diagnostics, Inc.

K number K040095

View details →

MVM 2004-01-20

AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA

Applicant Hycor Biomedical , Ltd.

K number K033744

View details →

MVM 2003-12-24

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

Applicant Immco Diagnostics, Inc.

K number K032571

View details →

MVM 2001-07-09

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA

Applicant Inova Diagnostics, Inc.

K number K011570

View details →

MVM 2001-07-09

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

Applicant Inova Diagnostics, Inc.

K number K011566

View details →

MVM 2001-04-24

EUROSPITAL EU-TTG IGA UMANA

Applicant Scimedx Corp.

K number K010625

View details →

MVM 2000-08-04

IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.

Applicant Scimedx Corp.

K number K002107

View details →

MVM 2000-02-18

EU-TTG IGA ELISA

Applicant Scimedx Corp.

K number K994379

View details →

MVM 1999-12-21

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA

Applicant The Binding Site, Ltd.

K number K993612

View details →

MVM 1999-11-01

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD

Applicant Medica, Inc.

K number K993034

View details →

MVM 1999-10-15

ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST

Applicant Immco Diagnostics, Inc.

K number K992878

View details →

MVM 1999-01-28

QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA

Applicant Inova Diagnostics, Inc.

K number K984137

View details →

MVM 1998-10-22

MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS

Applicant The Binding Site, Ltd.

K number K981209

View details →

MVM 1998-08-27

QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA

Applicant Inova Diagnostics, Inc.

K number K982366

View details →