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Siemens ADVIA Centaur DHEAS assay - HSA Registration DE0017054

Access comprehensive regulatory information for Siemens ADVIA Centaur DHEAS assay in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0017054 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on April 20, 2015.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0017054
Siemens ADVIA Centaur DHEAS assay
HSA Registration Number: DE0017054
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Product Description

The ADVIA Centaurยฎ DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0017054
Registration Date
April 20, 2015
Change Notification Approval Date
May 27, 2022
Retention Due Date
April 19, 2026
Product Owner
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
ADVIA Centaur Wash 1 ADVIA Centaur Wash 1 ADVIA Centaur DHEA-SO4 (DHEAS) ADVIA Centaur DHEAS Master Curve Material ADVIA Centaur Multi-Diluent 1 ADVIA Centaur Immunoassay System ADVIA Centaur XP Immunoassay System ADVIA Centaurยฎ XP Immunoassay System ADVIA Centaur Multi-Diluent 1 ADVIA Centaur Multi-Diluent 1
Model Identifier(s)
01137199 (112351) 03773025 06489701 06489752 07293184 (110312) 078-A002R02 078-A011-03 078-A011-R03 07907174 (110313) 09348792 (672177)