PharmiWeb

Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic. 1 FDA CLIA-waived tests broaden access to ...
Technology Networks

Roche Receives FDA Clearance With CLIA Waiver for Its First Molecular Point-of-Care Test

Roche’s cobas liat Bordetella test earns FDA clearance, delivering accurate whooping cough results in 15 minutes.
Yahoo Finance

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 ...
Pharm Exec

FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test

The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab ...
Pharmabiz

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 ...
Modern Healthcare

FDA warns of potential false positive results with Roche Cobas rapid coronavirus, flu test

The US Food and Drug Administration released a letter on Friday warning clinical laboratory and point-of-care staff, as well as healthcare providers, that false positive results for Roche's test for ...