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Aptiva® Celiac Disease IgA Reagent

INOVA DIAGNOSTICS, INC. · Model 724120 · UDI-DI 08430793040532

MVM MST NSU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives

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.