Roffe International BUZUD Influenza A/B Antigen Rapid Test for Self-testing - HSA Registration DE0510657
Access comprehensive regulatory information for Roffe International BUZUD Influenza A/B Antigen Rapid Test for Self-testing in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510657 and owned by Roffe International Holdings Pte Ltd. The device was registered on April 30, 2025.
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 Influenza A & B Ag Rapid Test Cassette (Swab) is an in vitro chromatographic immunoassay designed for the qualitative and differential detection of Influenza A (including subtype H1N1) and Influenza B nucleoprotein antigens. It is intended for use with nasal swab specimens from individuals exhibiting symptoms such as sudden onset of fever, dry cough, headache, and muscle or joint pain. This test serves as an aid in the rapid diagnosis of Influenza A and B viral infections. It is strictly for in vitro diagnostic use and is intended for self-testing.