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NOVA Lite® Monkey Oesophagus IFA Kit

INOVA DIAGNOSTICS, INC. · Model 704150 · UDI-DI 08426950557586

MVM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 25 x Monkey Oesophagus – 10-well slide 2. 1 x 1mL Pemphigus Positive Control (prediluted) 3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted) 4. 1 x 1mL IFA System Negative Control (prediluted) 5. 1 x 15mL FITC IgG (H&L), monkey adsorbed Conjugate 6. 1 x 15mL Anti-Human IgA (α) AFF FITC 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II concentrate (x40) 9. 1 x 10mL Mounting Medium 10. 25 x Coverslips 11. 1 x instruction leaflet

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.