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Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA product code OIU · Class 2 · Immunology

8
Registered devices
11
Adverse events
0
Recalls
5
510(k) clearances

Devices with this code

ARCHITECT — Abbott GmbHLumipulse G HE4 Immunoreaction Cartridges — FUJIREBIO INC.ARCHITECT — Abbott GmbHElecsys HE4 — Roche Diagnostics GmbHAlinity — Abbott GmbHHE4 EIA — Fujirebio Diagnostics ABElecsys HE4 Assay — Roche Diagnostics GmbHARCHITECT — Abbott GmbH

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.