Jiangsu Medomics SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) - HSA Registration DE0508796
Access comprehensive regulatory information for Jiangsu Medomics SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) 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 DE0508796 and owned by Jiangsu Medomics Medical Technology Co., Ltd.. The device was registered on December 28, 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.
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2, Influenza A and Influenza B virus antigen in swab samples from individuals suspected of COVID-19, Influenza A and Influenza B within the first seven days of symptom onset. SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) shall not be used as sole basis to diagnose or exclude SARS- CoV-2, Influenza A and Influenza B infection.

