Abbott Rapid Diagnostics Panbio™ COVID-19 Antigen Self-Test - HSA Registration DE0508190
Access comprehensive regulatory information for Abbott Rapid Diagnostics Panbio™ COVID-19 Antigen Self-Test 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 DE0508190 and owned by Abbott Rapid Diagnostics Jena GmbH. The device was registered on June 14, 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 Panbio™ COVID-19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen (Ag). The Panbio™ COVID-19 Antigen Self-Test is intended to be used manually by untrained lay users (self testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. Children under 14 years should be supported by an adult.