Abbott Alinity m SARS-CoV-2 - HSA Registration DE0508132
Access comprehensive regulatory information for Abbott Alinity m SARS-CoV-2 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 DE0508132 and owned by Abbott Molecular Inc. The device was registered on May 26, 2023.
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 SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare provider, from patients suspected of COVID-19 infection.