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Abbott Alinity i Thyroglobulin - HSA Registration DE0505843

Access comprehensive regulatory information for Abbott Alinity i Thyroglobulin in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0505843 and owned by Abbott GmbH. The device was registered on June 03, 2021.

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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CLASS C IVD
DE0505843
Abbott Alinity i Thyroglobulin
HSA Registration Number: DE0505843
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Product 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).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0505843
Registration Date
June 03, 2021
Change Notification Approval Date
December 23, 2024
Retention Due Date
June 02, 2025
Product Owner
Short Name
Abbott GmbH
Address
Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Thyroglobulin Assay Files Thyroglobulin Calibrators Thyroglobulin Controls Thyroglobulin Reagent Kit Thyroglobulin Reagent Kit
Model Identifier(s)
09P49-1A 09P4901 09P4910 09P4922 09P4932