SD Biosensor STANDARD™ Q COVID/Flu Ag Combo - HSA Registration DE0510390
Access comprehensive regulatory information for SD Biosensor STANDARD™ Q COVID/Flu Ag Combo 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 DE0510390 and owned by SD Biosensor, Inc.. The device was registered on February 26, 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 STANDARD Q COVID/Flu Ag Combo Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 and Influenza A and Influenza B present in human nasopharyngeal specimens. The STANDARD Q COVID/Flu Ag Combo Test for rapid detection of SARS-CoV-2, Influenza A and Influenza B is a differentiated test, such that SARS-CoV-2 viral antigens can be distinguished from Influenza A or Influenza B viral antigens from a single specimen using a single device. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2, Influenza A or Influenza B infection in patient with clinical symptoms with viral infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2, Influenza A or Influenza B infection.