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ROMA

Fujirebio Diagnostics, Inc. · Model 404-10US · UDI-DI 00869164000024

ONX Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
5
Facilities

Description

ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

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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.