SSI Diagnostica IMMUVIEW® S. pneumoniae and L. pneumophila Urinary Antigen Test - HSA Registration DE0509328
Access comprehensive regulatory information for SSI Diagnostica IMMUVIEW® S. pneumoniae and L. pneumophila Urinary Antigen Test in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509328 and owned by SSI Diagnostica A/S. The device was registered on May 30, 2024.
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 ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infections by detection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.