Abbott Diagnostics Scarborough BinaxNOW™ Streptococcus pneumoniae Antigen card System - HSA Registration DE0506944
Access comprehensive regulatory information for Abbott Diagnostics Scarborough BinaxNOW™ Streptococcus pneumoniae 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 DE0506944 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on June 08, 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.
The BinaxNOW™ Streptococcus pneumoniae Antigen Card (BinaxNOW™ Streptococcus pneumoniae) is an in vitro rapid immunochromatographic (ICT) assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis. The BinaxNOW™ S. pneumoniae Antigen Card can be read visually or used in conjunction with the DIGIVAL™ Reader.