Bio-Rad UriSelect 4 - HSA Registration DE0014588
Access comprehensive regulatory information for Bio-Rad UriSelect 4 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 DE0014588 and owned by Bio-Rad France. The device was registered on January 06, 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.
UriSelect4 is a non-selective chromogenic agar medium used as an aid in the diagnosis of urinary tract infections (UTIs) by the isolation, semi-quantitative enumeration and identification of urinary tract pathogens. It is intended for suspected patients with clinical symptoms such as pain when urinating, possibly with fever, and for the detection of asymptomatic bacteriuria in selected patients groups, such as pregnant women. UriSelect4 allows for: • The direct identification of the bacterial species most often responsible for UTIs, namely Escherichia coli, Enterococcus spp. and Proteus mirabilis; • The presumptive identification of some other urinary pathogens, in particular Klebsiella-Enterobacter-Serratia- Citrobacter (KESC group), Proteus-Morganella- Providencia (PMP group) and Staphylococcus saprophyticus.