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HSA · registration DE0505843

Abbott Alinity i Thyroglobulin

SingaporeImmunologyClass CAbbott GmbH
Verified
Official record identity
Registration number
DE0505843
Model name
Thyroglobulin Assay Files; Thyroglobulin Calibrators; Thyroglobulin Controls; Thyroglobulin Reagent Kit; Thyroglobulin Reagent Kit
Model identifier
09P49-1A; 09P4901; 09P4910; 09P4922; 09P4932
Registration date
June 03, 2021
Source update date
December 23, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Immunology
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Published parties
Product owner
Abbott GmbH
Registrant / registration holder
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official description

The Alinity i Thyroglobulin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of thyroglobulin in human serum and plasma on the Alinity i analyzer. Determination of thyroglobulin is used as an aid in monitoring after total thyroid ablation (thyroidectomy).

Additional source fields
Product owner address
Max-Planck-Ring 2, 65205 Wiesbaden, Germany
Registrant address
3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.