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Singapore HSA registration DE0019404

Abbott Diagnostics Technologies Afinion ACR

Singapore flagSingapore·CLASS B IVD·Abbott Diagnostics Technologies AS·Registered July 13, 2017
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0019404
Registration Date
July 13, 2017
Change Notification Approval Date
June 01, 2021
Retention Due Date
July 12, 2025
Product description
Alere Afinion™ ACR is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and ACR aids in the early diagnosis of nephropathy.
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 ACR CONTROL AFINION ACR Afinion Analyzer Cleaning Kit
Model Identifier(s)
1116049 1116061 1116770 1116771 1116779 1116781 1116784
About this record

Access comprehensive regulatory information for Abbott Diagnostics Technologies Afinion ACR 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 DE0019404 and owned by Abbott Diagnostics Technologies AS. The device was registered on July 13, 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