Eu-tTG IgG

EUROSPITAL SPA · Model 9166 · UDI-DI 08028169204048

MVM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml). 4. Control 1: 1x1.5 mL vial. 5. Control 2: 1x1.5 mL vial. 6. Sample Diluent (10x): 1 x20mL vial. 7. Substrate: 1 x15 ml vial. 8. Wash solution (20x): 1x50 mL vial. 9. Stop Solution: 1 x15 ml vial.

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 elevated bias between th

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.