Anti-Müllerian Hormone Test System
FDA product code PQO · Class II (moderate risk) · 21 CFR 862.1092 · Clinical Chemistry
An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
4510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH)PQO · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/02/2023SE |
| K223679 | Access AMHPQO · Traditional | Beckman Coulter, Inc. | 02/03/2023SE |
| K203757 | Elecsys AMHPQO · Traditional | Roche Diagnostics | 06/10/2022SE |
| K170524 | Access AMHPQO · Traditional | Beckman Coulter, Inc. | 11/13/2017SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0737-2026 Class II | Female Fertility TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |