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QUANTA Lite® h-tTG IgG ELISA Bulk Pack

INOVA DIAGNOSTICS, INC. · Model 708755.10 · UDI-DI 08426950596158

MVM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 10x h-tTG IgG ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted h-tTG IgG ELISA Low Positive 4. 5x 1.2mL prediluted h-tTG IgG ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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.