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FilmArray® Pneumonia Panel (Pneumo)

BIOFIRE DIAGNOSTICS, LLC · Model RFIT-ASY-0145 · UDI-DI 00815381020185

QDP Prescription
3
510(k) clearances
7
Adverse events
0
Recalls
1
Facilities

Description

IVD reagent kit containing 6 tests

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

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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.