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Siemens IMMULITE 2000 TSI - HSA Registration DE0019371

Access comprehensive regulatory information for Siemens IMMULITE 2000 TSI 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 DE0019371 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on June 29, 2017.

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
DE0019371
Siemens IMMULITE 2000 TSI
HSA Registration Number: DE0019371
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Product Description

For in vitro diagnostic use with the IMMULITEยฎ 2000 Systems Analyzers โ€” for the quantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptor (TSHR) in human serum or EDTA and lithium heparin plasma. The determination of thyroid stimulating autoantibodies, in conjunction with other clinical and laboratory findings, is used as an aid in the assessment of patients with suspected Gravesโ€™ disease.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0019371
Registration Date
June 29, 2017
Change Notification Approval Date
July 09, 2020
Retention Due Date
June 28, 2025
Product Owner
Short Name
Siemens Healthcare Diagnostics Products Limited
Address
Gly Rhonwy, Llanberis, Gwynedd LL55 4EL, UNITED KINGDOM
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)
IMMULITE 2000 System IMMULITE 2000 XPi System Probe Cleaning Kit IMMULITE 2000 TSI Multi-Diluent 2 Multi-Diluent 2 Probe Wash Chemiluminescent Substrate
Model Identifier(s)
030002 030002-33 L2KPM L2KSI2 L2M2Z L2M2Z4 L2PWSM L2SUBM