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Anti-Müllerian Hormone Test System

FDA product code PQO · Class 2 · Clinical Chemistry

11
Registered devices
14
Adverse events
1
Recalls
5
510(k) clearances

Devices with this code

Elecsys AMH — Roche Diagnostics GmbHElecsys AMH — Roche Diagnostics GmbHADVIA Centaur AMH Kit — Siemens Healthcare Diagnostics Inc.AMH AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.AMH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Access AMH — Beckman Coulter, Inc.AMH AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Atellica IM AMH — Siemens Healthcare Diagnostics Inc.AMH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Elecsys AMH — Roche Diagnostics GmbHElecsys AMH — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

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