Anti-müllerian Hormone Test System
Clinical Chemistry · 21 CFR 862.1092
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.
Recent MDR events
14 adverse event reports on file
- ELECSYS AMHFeb 4, 2025MalfunctionRoche Diagnostics1823260-2025-00326
- AMH ELECSYS E2G 100Apr 23, 2024MalfunctionRoche Diagnostics1823260-2024-01247
- AMH ELECSYS E2G 100Mar 6, 2023MalfunctionRoche Diagnostics1823260-2023-00699
- ELECSYS AMHNov 20, 2022MalfunctionRoche Diagnostics1823260-2022-03691
- ELECSYS AMHOct 19, 2022MalfunctionRoche Diagnostics1823260-2022-03255
- ELECSYS AMH SYSTEMMar 26, 2020MalfunctionRoche Diagnostics1823260-2020-00858
- ELECSYS AMH SYSTEMJul 17, 2019MalfunctionRoche Diagnostics1823260-2019-02632
- ELECSYS AMH SYSTEMMay 28, 2019MalfunctionRoche Diagnostics1823260-2019-01985
- ELECSYS AMH SYSTEMApr 15, 2019MalfunctionRoche Diagnostics1823260-2019-01464
- ELECSYS AMH SYSTEMApr 15, 2019MalfunctionRoche Diagnostics1823260-2019-01465
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
12 firms currently registered for this product code
Immunotech Sas, A Beckman Coulter Company
MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Immunocentrix Corporation
Canoga Park, CA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Ansh Labs, Llc
Webster, TX, US
Monobind, Inc.
Lake Forest, CA, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
510(k) clearances
5 clearances for this product code
- Siemens Healthcare Diagnostics, Inc.Jun 2, 2023
K221801 · ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- Beckman Coulter, Inc.Feb 3, 2023
K223679 · Access AMH
- Roche DiagnosticsJun 10, 2022
K203757 · Elecsys AMH
- Beckman Coulter, Inc.Nov 13, 2017
K170524 · Access AMH
- Roche DiagnosticsDec 19, 2016
DEN150057 · Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5