Bio-Rad β Lacta test - HSA Registration DE0019361
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.
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.