HSA · registration DE0510540

Siemens Atellica IM Anti‑Müllerian Hormone (AMH)

Name: Siemens Atellica IM Anti‑Müllerian Hormone (AMH) — HSA DE0510540
Creator: Siemens Healthcare Diagnostics Inc
Keywords: Siemens Atellica IM Anti‑Müllerian Hormone (AMH), Siemens Atellica IM Anti‑Müllerian Hormone (AMH), DE0510540, Immunology, HSA

SingaporeImmunologyClass BSiemens Healthcare Diagnostics Inc

Verified

Official record identity

Registration number: DE0510540
Model name: Atellica IM HCY DIL; Atellica IM Anti‑Müllerian Hormone (AMH); Atellica IM AMH QC
Model identifier: 10995608; 10998433; 11205265
Registration date: April 02, 2025

Classification

Risk class: Class B
Published category: Immunology

Published parties

Product owner: Siemens Healthcare Diagnostics Inc
Registrant / registration holder: SIEMENS HEALTHCARE PTE. LTD.

Official description

The Atellica® IM Anti‑Müllerian Hormone (AMH) assay is for in vitro diagnostic use in the quantitative determination of anti-Müllerian hormone (AMH) in human serum and plasma (lithium heparin) using the Atellica® Analyzer. The measurement of AMH, in conjunction with other clinical and laboratory findings, is used as an aid in the assessment of the ovarian reserve, and the prediction of poor ovarian response (≤ 4 oocytes retrieved) to controlled ovarian stimulation (COS).

Additional source fields

Product owner address: 511 Benedict Avenue, Tarrytown, NY 10591-5097, United States
Registrant address: 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.