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Singapore HSA registration DE0504345

Abbott Alinity i Galectin-3

Singapore flagSingapore·CLASS B IVD·Abbott GmbH·Registered April 08, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504345
Registration Date
April 08, 2020
Change Notification Approval Date
September 15, 2023
Retention Due Date
April 07, 2026
Product description
The Alinity i Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of galectin-3 in human serum and EDTA plasma on the Alinity i analyzer. The Alinity i Galectin-3 assay is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF).
Product Owner
Name
Abbott GmbH
Short Name
Abbott GmbH
Address
Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Alinity i Galectin-3 Assay File Alinity i Galectin-3 Calibrators Alinity i Galectin-3 Controls Alinity i Galectin-3 Reagent Kit
Model Identifier(s)
09P60-1A 09P6001 09P6010 09P6022
About this record

Access comprehensive regulatory information for Abbott Alinity i Galectin-3 in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0504345 and owned by Abbott GmbH. The device was registered on April 08, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD