Abbott Diagnostics Panbio™ COVID-19/Flu A&B Panel (Nasal) - HSA Registration DE0509498
Access comprehensive regulatory information for Abbott Diagnostics Panbio™ COVID-19/Flu A&B Panel (Nasal) 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 DE0509498 and owned by Abbott Rapid Dx Galway. The device was registered on July 05, 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 Panbio™ CODVID-19/Flu A&B Panel (Nasal) is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid proteins SARS-CoV-2 and nucleoproteins Influenza A&B antigens (Ag) in human nasal mid-turbinate (NMT) swab specimens from symptomatic individuals, who meet COVID-19 and/or Influenza clinical and/or epidemiological criteria. Panbio™ COVID-19/Flu A&B Panel (Nasal) is intended for use by trained professionals in a laboratory and near-patient setting as an aid in the diagnosis of SARS-CoV-2 and Influenza infection. It is not intended for self-testing.