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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 and Drug Administration (FDA) for its cobas liat sexually transmitted ...
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Roche wins breakthrough designation for Tau biomarker test for Alzheimer’s
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche’s Elecsys pTau217 plasma biomarker assay. The pTau217 assay was developed in collaboration with Eli ...
pharmaphorum5mon
Roche launches 'revolutionary' pathogen detection tech
Roche has introduced the first test based on a new technology – called TAGS – that it believes could revolutionise testing for infectious diseases by allowing high-throughput detection to be ...
Pharmabiz1mon
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels
Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted ...
The Scientist1y
Advances in Clinical Immunoassays: Applications in Oncology and Ophthalmology
Dr. Marianne Manchester Head, Immunoassay and Metabolites Lab Roche Innovation Center Basel Dr. Martina Thier Head, Immunoassay Lab Roche Innovation Center Basel ...