Singapore HSA registration DE0019361

Bio-Rad β Lacta test

Singapore flagSingapore·CLASS B IVD·Bio-Rad·Registered June 27, 2017
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0019361
Registration Date
June 27, 2017
Change Notification Approval Date
July 19, 2023
Retention Due Date
June 26, 2025
Product description
The β LACTA test is a manual qualitative colorimetric test used for detecting strains with decreased susceptibility to third-generation cephalosporins. This decreased susceptibility is due to the presence of specific enzymes in the bacteria. The test may be performed either directly with isolated colonies of Enterobacteriaceae or with bacterial pellets from positive blood cultures or urine, all from any patient suffering from bloodstream infections, urinary tract infections, etc. The β LACTA test provides an aid to diagnosis for the detection of Enterobacteriaceae with decreased susceptibility to third-generation cephalosporins, and it is not intended to replace conventional antimicrobial susceptibility testing methods.
Product Owner
Short Name
Bio-Rad
Address
3, bvd Raymond Poincare, 92430 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)
B Lacta test
Model Identifier(s)
68250
About this record

Access comprehensive regulatory information for Bio-Rad β Lacta test 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 DE0019361 and owned by Bio-Rad. The device was registered on June 27, 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.

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