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HSA · registration DE0017682

Siemens IMMULITE 1000, IMMULITE 2000 Thyroid Uptake

SingaporeClinical chemistryClass BSiemens Healthcare Diagnostics Products Limited
Verified
Official record identity
Registration number
DE0017682
Model name
IMMULITE® 2000 Thyroid Uptake (200 tests); IMMULITE® 2000 Thyroid Uptake (3000 tests); IMMULITE® 2000 Thyroid Uptake (600 tests); IMMULITE® 2000 Thyroid Uptake (6000 tests); Thyroid Uptake Bead Pack; Thyroid Uptake Reagent Wedge; IMMULITE®/IMMULITE 1000 Thyroid Uptake (100 tests); IMMULITE®/IMMULITE 1000 Thyroid Uptake (500 tests); Thyroid Uptake Test Units; Thyroid Uptake Reagent Wedge; Thyroid Uptake Test Adjustor
Model identifier
L2KTU2; L2KTU3M; L2KTU6; L2KTU6M; L2TU12; L2TUA2; LKTU1; LKTU5; LTU1; LTU2; LTUL
Registration date
December 01, 2015
Source update date
July 09, 2020
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
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Published parties
Product owner
Siemens Healthcare Diagnostics Products Limited
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official 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.

Additional source fields
Product owner address
Gly Rhonwy Llanberis,, Caernarfon Gwynedd LL55, 4EL, United Kingdom
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.