SD Biosensor STANDARD Q COVID-19 Ag Test - HSA Registration DE0508204
Access comprehensive regulatory information for SD Biosensor STANDARD Q COVID-19 Ag 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 DE0508204 and owned by SD Biosensor, Inc.. The device was registered on June 16, 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.
STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal or nasopharyngeal specimens. This product is intended for healthcare professionals at the clinical setup and point of care sites, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.