Abbott Diagnostics Scarborough BinaxNOW™ Legionella Urinary Antigen Card System - HSA Registration DE0506917
Access comprehensive regulatory information for Abbott Diagnostics Scarborough BinaxNOW™ Legionella Urinary Antigen Card System 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 DE0506917 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on May 31, 2022.
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.
BinaxNOW™ Legionella Urinary Antigen Card (BinaxNOW™ Legionella) is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection(Legionnaires’ Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods. BinaxNOW™ Legionella Urinary Antigen card can be read visually or used in conjunction with the DIGIVAL™.