Singapore HSA registration DE0017682
Siemens IMMULITE 1000, IMMULITE 2000 Thyroid Uptake
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Products Limited·Registered December 01, 2015Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0017682
- Registration Date
- December 01, 2015
- Change Notification Approval Date
- July 09, 2020
- Retention Due Date
- November 30, 2025
Product description
For in vitro diagnostic use with the IMMULITE 1000, IMMULITE 2000 Systems Analyzers — yields an index of thyroid hormone carrier protein levels in serum, to aid in the clinical assessment of thyroid status.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Products Limited
- Address
- Gly Rhonwy Llanberis,, Caernarfon 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 IMMULITE® 1000 System Version 6.5, software kit Kit, SW V5.22 Probe Cleaning Kit IMMULITE® 2000 Thyroid Uptake (200 tests) IMMULITE® 2000 Thyroid Uptake (3000 tests) IMMULITE® 2000 Thyroid Uptake (600 tests) IMMULITE® 2000 Thyroid Uptake (6000 tests) Probe Wash Chemiluminescent Substrate Thyroid Uptake Bead Pack Thyroid Uptake Reagent Wedge Sample Cup Holders Probe Cleaning Kit IMMULITE®/IMMULITE 1000 Thyroid Uptake (100 tests) IMMULITE®/IMMULITE 1000 Thyroid Uptake (500 tests) Probe Wash Module Reaction Tubes (disposable) Sample Cup Caps (optional) Sample Cups (disposable) Chemiluminescent Substrate Thyroid Uptake Test Units Thyroid Uptake Reagent Wedge Thyroid Uptake Test Adjustor
- Model Identifier(s)
- 030002 030002-33 030006 10792911 10914401 L2KPM L2KTU2 L2KTU3M L2KTU6 L2KTU6M L2PWSM L2SUBM L2TU12 L2TUA2 LCHx-y LKPM LKTU1 LKTU5 LPWS2 LRXT LSCC LSCP LSUBX LTU1 LTU2 LTUL
About this record
Access comprehensive regulatory information for Siemens IMMULITE 1000, IMMULITE 2000 Thyroid Uptake 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 DE0017682 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on December 01, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD