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 ...
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 ...
Yahoo Finance

Roche (RHHBY) Launches Cobas Test for Bacterial Infections

Roche Holdings AG RHHBY recently launched CE-IVD – the cobas MRSA/SA nucleic acid test. The test will be used on the cobas Liat System for the qualitative detection and differentiation of ...
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 ...
Finanznachrichten

F. Hoffmann-La Roche Ltd: 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 ...