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HSA · registration DE0019371

Siemens IMMULITE 2000 TSI

SingaporeImmunologyClass BSiemens Healthcare Diagnostics Products Limited
Verified
Official record identity
Registration number
DE0019371
Model name
IMMULITE 2000 TSI; Multi-Diluent 2; Multi-Diluent 2
Model identifier
L2KSI2; L2M2Z; L2M2Z4
Registration date
June 29, 2017
Source update date
July 09, 2020
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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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® 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.

Additional source fields
Product owner address
Gly Rhonwy, Llanberis, 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.