Singapore HSA registration DE0505843
Abbott Alinity i Thyroglobulin
Singapore·CLASS C IVD·Abbott GmbH·Registered June 03, 2021Device 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 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).
Product Owner
- Name
- Abbott GmbH
- 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
About this record
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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