SD Biosensor STANDARD™ M10 Flu/RSV/SARS-CoV-2 - HSA Registration DE0510659
Access comprehensive regulatory information for SD Biosensor STANDARD™ M10 Flu/RSV/SARS-CoV-2 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 DE0510659 and owned by SD Biosensor, Inc.. The device was registered on May 02, 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.
STANDARD M10 Flu/RSV/SARS CoV 2 test is a multiplex real time RT PCR test intended for use with STANDARD M10 system for the qualitative detection of Influenza A, Influenza B, RSV and SARS CoV 2 nucleic acids in human nasopharyngeal swab collected from individuals suspected of a respiratory disease by their healthcare provider Positive results are indicative of the presence of Influenza A, Influenza B, RSV and/or SARS CoV 2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Negative results should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. STANDARD M10 Flu/RSV/SARS CoV 2 test is intended to be performed by trained users in laboratory setting.