Singapore HSA registration DE0019371
Siemens IMMULITE 2000 TSI
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Products Limited·Registered June 29, 2017Device 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 description
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — 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 Graves’ disease.
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
About this record
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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