Abbott Alinity m HSV 1 & 2/ VZV - HSA Registration DE0509787
Access comprehensive regulatory information for Abbott Alinity m HSV 1 & 2/ VZV in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509787 and owned by Abbott Molecular Inc. The device was registered on September 16, 2024.
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 HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2), and Varicella Zoster Virus (VZV) DNA from clinician-collected lesion swab specimens(including cutaneous or mucocutaneous lesion specimens). The Alinity m HSV 1 & 2 / VZV assay is intended for use as an aid in the diagnosis of HSV-1, HSV-2 and/or VZV infections in symptomatic patients.