Abbott Alinity m HIV-1 - HSA Registration DE0505410
Access comprehensive regulatory information for Abbott Alinity m HIV-1 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 DE0505410 and owned by Abbott Molecular Inc. The device was registered on January 28, 2021.
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 HIV-1 assay is an in RT-PCR assay for use with the automated Alinity m System to detect and quantitate HIV-1 RNA. The Alinity m HIV-1 assay is intended for use in the clinical management of HIV-1 infected individuals.The Alinity m HIV-1 assay may be used to monitor disease prognosis by measuring the baseline plasma HIV-1 RNA level and to assess viral response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. Performance for quantitative results is not established with serum specimens. The Alinity m HIV-1 assay may also be used as a diagnostic test to aid in the diagnosis of HIV-1 infection by confirming HIV-1 infection in individuals that have repeat reactive results with HIV immunoassays. Performance of the diagnostic confirmatory interpretation is established with both plasma and serum specimens. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for HIV.