Singapore HSA registration DE0014588
Bio-Rad UriSelect 4
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0014588
- Registration Date
- January 06, 2014
- Change Notification Approval Date
- June 08, 2023
- Retention Due Date
- January 05, 2026
Product description
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.
Product Owner
- Name
- Bio-Rad France
- Short Name
- Bio-Rad France
- Address
- 3, Boulevard Raymong Poincare, 90430 Marnes-la-Coquette, FRANCE
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- UriSelect4 UriSelect 4 UriSelect4 UriSelect4
- Model Identifier(s)
- 12013236 63726 63727 64694
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD