Antibodies, Gliadin
Immunology · 21 CFR 866.5750
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- Phadia US IncOpen, ClassifiedJun 30, 2023
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002)
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Z-2040-2023 · View FDA record ↗ - Phadia US IncOpen, ClassifiedJun 30, 2023
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, ED
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Z-2041-2023 · View FDA record ↗ - Diamedix CorporationTerminatedSep 16, 2008
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. -
Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.
Z-1684-2008 · View FDA record ↗
Registered firms
50 firms currently registered for this product code
Bio-rad Laboratories, Inc.
Hercules, CA, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Theratest Laboratories, Inc.
Lombard, IL, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Phadia Us Inc.
Portage, MI, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Aesku.diagnostics Gmbh&co.kg
WENDELSHEIM Rhineland-Palatinate, DE
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Phadia Ab
UPPSALA, SE
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Eurospital S.p.a.
TRIESTE, IT
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Drg Instruments Gmbh
MARBURG Hesse, DE
510(k) clearances
42 clearances for this product code
- Immco Diagnostics, Inc.Jul 28, 2017
K163177 · ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- Aesku DiagnosticsDec 5, 2013
K132082 · AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
- Grifols USA, LLCDec 14, 2012
K113377 · GLIADIN IGA AND GLIADIN LGA
- Inova Diagnostics, Inc.Sep 20, 2012
K113863 · QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
- Inova Diagnostics, Inc.Oct 20, 2011
K111414 · QUANTA FLASH (TM) DGP SCREEN
- Phadia US, Inc.Aug 13, 2010
K093459 · ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- Immco Diagnostics, Inc.Feb 4, 2010
K091522 · IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
- Euroimmun Us, Inc.Aug 7, 2009
K083053 · EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)