Abbott Alinity m System - HSA Registration DE0505183
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.
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