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Autoantibodies, Endomysial(Tissue Transglutaminase)
FDA product code MVM · Class 2 · Immunology
110
Registered devices
2
Adverse events
1
Recalls
40
510(k) clearances
Devices with this code
QUANTA Lite® h-tTG IgG ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONIMMCO DIAGNOSTIC — IMMCO DIAGNOSTICS, INC.EliA Celikey IgA Well — Phadia ABIFA: Oesophagus (Monkey) IgA EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGBioPlex 2200 — BIO-RAD LABORATORIES, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONNOVA Lite® Monkey Oesophagus IFA Kit — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONNOVA Lite® Monkey Oesophagus IFA Kit — INOVA DIAGNOSTICS, INC.QUANTA Lite® tTG ELISA — INOVA DIAGNOSTICS, INC.IFA: Oesophagus (Monkey) IgA — EUROIMMUN Medizinische Labordiagnostika AGQUANTA Flash® h-tTG IgG Reagents — INOVA DIAGNOSTICS, INC.QUANTA Lite® h-tTG IgA ELISA — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA IgA Calibrator Well — Phadia ABIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA: Oesophagus (Monkey) IgA EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGMeDiCa — SCIMEDX CORPORATIONEliA IgA Curve Control Strip — Phadia ABEliA IgA Curve Control — 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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