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Antibodies, Gliadin
FDA product code MST · Class 2 · Immunology
74
Registered devices
0
Adverse events
3
Recalls
42
510(k) clearances
Devices with this code
Anti-Gliadin (GAF-3X) ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.Autostat II Anti-Gliadin IgA — HYCOR BIOMEDICAL LLCBioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Gliadin IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.AESKULISA® Glia-A — Aesku.Diagnostics GmbH & Co. KGAESKULISA® DGP-A — Aesku.Diagnostics GmbH & Co. KGAESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KGGliadin IgG ELISA — DRG International IncAutoimmune EIA — BIO-RAD LABORATORIES, INC.ImmunoCAP Gliadin IgA/IgG Control Low — Phadia ABQUANTA Lite® Gliadin IgA II ELISA — INOVA DIAGNOSTICS, INC.Aptiva® Celiac Disease IgG Reagent — INOVA DIAGNOSTICS, INC.ImmunoCAP IgA/IgG Calibrator ImmunoCAP — Phadia ABBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.AESKULISA® DGP-Check — Aesku.Diagnostics GmbH & Co. KGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.ImmunoCAP Specific IgA Curve Controls — Phadia ABQUANTA Lite® Gliadin IgG ELISA — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-01 | Phadia US Inc | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrume |
| 2023-05-01 | Phadia US Inc | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrume |
| 2008-03-21 | Diamedix Corporation | 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 |
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