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Singapore HSA registration DE0019318

Bio-Rad B Carba Test

Singapore flagSingapore·CLASS C IVD·Bio-Rad·Registered June 14, 2017
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0019318
Registration Date
June 14, 2017
Change Notification Approval Date
August 29, 2022
Retention Due Date
June 13, 2025
Product description
The β CARBA test is a manual qualitative colorimetric test used for detecting strains with decreased susceptibility to carbapenems due to the production of carbapenemases. The test may be performed directly with isolated colonies of Enterobacteriaceae from any patient suffering from bloodstream infections, urinary tract infections, etc. The β CARBA test provides an aid to diagnosis for the detection of Carbapenemase-Producing Enterobacteriaceae (CPE) and it is not intended to replace conventional antimicrobial usceptibility testing methods.
Product Owner
Name
Bio-Rad
Short Name
Bio-Rad
Address
3, bvd Raymond Poincare, 92430 Marnes-La-Coquette, FRANCE
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
B Carba Test
Model Identifier(s)
68260
About this record

Access comprehensive regulatory information for Bio-Rad B Carba Test 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 DE0019318 and owned by Bio-Rad. The device was registered on June 14, 2017.

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 C IVD