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Antibodies, Gliadin
FDA product code MST · Class 2 · Immunology
76
Registered devices
0
Adverse events
3
Recalls
42
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.a-GliaPep IgA — EUROSPITAL SPAAESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KGAnti-Gliadin (GAF-3X) ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGAutoimmune EIA — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA Gliadin IgA Well — Phadia ABAutostat II Anti-Gliadin IgA — HYCOR BIOMEDICAL LLCImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Lite® h-tTG /DGP Screen ELISA — INOVA DIAGNOSTICS, INC.EliA Gliadin IgG Well — Phadia ABQUANTA Flash® DGP IgA Reagents — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Lite® Celiac DGP Screen ELISA — INOVA DIAGNOSTICS, INC.QUANTA Flash® DGP IgG Reagents — INOVA DIAGNOSTICS, INC.Gliadin IgA ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAESKULISA® Glia-A — Aesku.Diagnostics GmbH & Co. KGImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.EliA GliadinDP IgA Well — Phadia AB
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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