Remel Staphaurex - HSA Registration DE0016003
Access comprehensive regulatory information for Remel Staphaurex in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0016003 and owned by Remel Europe Limited. The device was registered on July 17, 2014.
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.
Staphaurex™ is a qualitative latex slide agglutination test to aid in the differentiation of staphylococcal isolates grown on agar which possess clumping factor and/or protein A, particularly Staphylococcus aureus, from staphylococci which possess neither of these factors. Used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having bacterial infections. The device is not automated, is for professional use only and is not a companion diagnostic.