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 ...
Pharmabiz

US FDA grants 510(k) clearance to Roche's Strep A test on cobas Liat System

Roche announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA in throat ...
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 ...
Medscape

FDA Clears First Real-time PCR Test for Influenza A/B

The US Food and Drug Administration (FDA) has cleared the cobas Influenza A/B test for use on the cobas Liat System, according to manufacturer Roche. It is the first Clinical Laboratory Improvement ...
The Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...