Home › INOVA DIAGNOSTICS, INC. › QUANTA Flash® MPO Reagents

QUANTA Flash® MPO Reagents

INOVA DIAGNOSTICS, INC. · Model 701130 · UDI-DI 08426950627685

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1. QUANTA Flash MPO Reagent Cartridge contains the following reagents for 100 determinations: a. MPO coated paramagnetic beads, in a liquid containing buffer, protein stabilizers and preservative. b. Assay Buffer – colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives. c. Tracer IgG– Isoluminol labeled anti-human IgG antibodies, containing buffer, protein stabilizers and preservative. d. Sample Dilution Buffer – colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives.

Recalls

Date	Firm	Reason
2023-05-24	Phadia Ab	Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.