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Autoantibodies, Endomysial(Tissue Transglutaminase)
FDA product code MVM · Class 2 · Immunology
112
Registered devices
2
Adverse events
1
Recalls
40
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.EliA Celikey IgA Well — Phadia ABAnti Tissue Transglutaminase-A (Anti-tTg-A) ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Endomysial(ME)96 Test(L) — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONIFA: Oesophagus (Monkey) IgA — EUROIMMUN Medizinische Labordiagnostika AGIFA: Oesophagus (Monkey) IgA — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Eu-tTG IgA — EUROSPITAL SPAQUANTA Flash® h-tTG IgG Reagents — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA IgA Curve Control — Phadia ABQUANTA Lite® tTG ELISA — INOVA DIAGNOSTICS, INC.QUANTA Lite® h-tTG IgA ELISA — INOVA DIAGNOSTICS, INC.IFA: Oesophagus (Monkey) IgA — EUROIMMUN Medizinische Labordiagnostika AGBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Lite® h-tTG /DGP Screen ELISA — INOVA DIAGNOSTICS, INC.QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp) — INOVA DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONEliA IgA Conjugate 200 — Phadia AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-03 | Bio-Rad Labs | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elev |
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