HSA · registration DE0510693Siemens Atellica IM DHEAS2
SingaporeImmunologyClass BSiemens Healthcare Diagnostics Inc
Official record identity
- Registration number
- DE0510693
- Model name
- Atellica IM Multi‑Diluent 3; Atellica IM DHEAS2; Atellica IM DHEAS2 MCM
- Model identifier
- 10995645; 11209193; 11209195
- Registration date
- May 07, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Siemens Healthcare Diagnostics Inc
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
Official description
The Atellica® IM DHEAS2 assay is for in vitro diagnostic use in the quantitative determination of DHEAS in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzer. Measurements of DHEAS are used in the evaluation of adrenal gland function and as an aid in the diagnosis of disorders associated with the adrenal glands.
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.