ADVIA Centaur® Anti-Müllerian Hormone (AMH)

ADVIA Centaur® Anti-Müllerian Hormone (AMH) is an FDA 510(k)-cleared medical device (K221801) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2023. Regulation: 8.