Pure Global
Singapore HSA registration DE0505183

Abbott Alinity m System

Singapore flagSingapore·CLASS D IVD·Abbott Molecular Inc·Registered November 30, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0505183
Registration Date
November 30, 2020
Change Notification Approval Date
August 29, 2024
Retention Due Date
November 29, 2025
Product description
The Alinity m System is intended for use by a trained laboratory professional to perform Real-Time PC on clinical specimens to provide quantitative and qualitative detection of nucleic acid sequences for diagnostic purposes. The intended use of the system comprises automatic performance of the following functions: Isolation of nucleic acid from specimens, amplification of specific nucleic acid targets by PCR, detection of the amplified product, analysis of the response data to produce quantitative or qualitative results
Product Owner
Name
Abbott Molecular Inc
Short Name
Abbott Molecular Inc
Address
1300 E. Touhy Avenue, Des Plaines, IL, 60018, UNITED STATES
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 m System
Model Identifier(s)
08N53-002
About this record

Access comprehensive regulatory information for Abbott Alinity m System in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0505183 and owned by Abbott Molecular Inc. The device was registered on November 30, 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 D IVD