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Singapore HSA registration DE0019523

Abbott Diagnostics Technologies Afinion HbA1c

Singapore flagSingapore·CLASS B IVD·Abbott Diagnostics Technologies AS·Registered August 22, 2017
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0019523
Registration Date
August 22, 2017
Change Notification Approval Date
June 01, 2021
Retention Due Date
August 21, 2025
Product description
Alere Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (hemoglobin A1c, HbA1c) in human whole blood. The measure of HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. This test can be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk of developing diabetes.
Product Owner
Name
Abbott Diagnostics Technologies AS
Short Name
Abbott Diagnostics Technologies AS
Address
Kjelsåsveien 161, P.O. Box 6863 Rodeløkka, NO-0504 Oslo, NORWAY
Registrant
Name
Bio Laboratories Pte Ltd
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Importer
Name
BIO LABORATORIES PTE LTD
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
Model Name(s)
Alere Afinion AS100 Analyzer Alere Afinion Data Connectivity Converter AFINION 2 AFINION 2 (refurbished) Afinion Analyzer Cleaning Kit AFINION HbA1c CONTROL AFINION HbA1c
Model Identifier(s)
1116049 1116061 1116770 1116771 1116784  1116793  1116795
About this record

Access comprehensive regulatory information for Abbott Diagnostics Technologies Afinion HbA1c 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 DE0019523 and owned by Abbott Diagnostics Technologies AS. The device was registered on August 22, 2017.

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