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QUANTA Flash® LKM-1 Reagents

INOVA DIAGNOSTICS, INC. · Model 701298 · UDI-DI 08426950767008

NBS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations: a. LKM-1 coated paramagnetic beads, lyophilized. b. Assay buffer – colored pink, containing protein stabilizers and preservatives. c. Tracer IgG – Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. 2. Resuspension buffer - colored clear, containing buffer, protein stabilizers and preservatives."

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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.