Pharmabiz1mon
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels
The cobas liat system utilises gold-standard PCR technology to provide results in 20 minutes or less. The cobas liat assays are CLIA waived, enabling healthcare professionals to perform molecular ...
GlobalData on MSN1mon
Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Roche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food ...
Mena FN2mon
Roche Receives FDA Clearance With CLIA Waiver For Cobas® Liat Molecular Tests To Diagnose Sexually Transmitted Infections At The Point Of Care
2 The cobas liat system utilises gold-standard PCR technology to provide results in 20 minutes or less. The cobas liat assays are CLIA waived*, enabling healthcare professionals to perform ...
Hosted on MSN1mon
Roche gets FDA clearance for STI test panels
Roche (OTCQX:RHHBY) has received FDA clearance with a CLIA waiver for its cobas liat sexually transmitted infection, or STI, multiplex assay panels. The tests will be available exclusively in the ...