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NOVA Lite®Rat Liver , Kidney, Stomach Kit

INOVA DIAGNOSTICS, INC. · Model 704180 · UDI-DI 08426950545798

DBL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 25 x Rat liver, kidney, stomach slide (10-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 15mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25 PBS II Buffer (x40 conc) 9. 1 x 10mL Mounting Medium 10. 50 x Blotters 11. 25 x Coverslips 12. 1 x instruction leaflet

Recalls

Date	Firm	Reason
2008-07-29	Bio-Rad Laboratories	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

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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.