Nasdaq

Roche (RHHBY) Launches Cobas Test for Bacterial Infections

Roche Holdings AGRHHBY 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 ...
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 ...
Pharmabiz

US FDA grants CLIA waiver for Roche's cobas Liat PCR system and Strep A assay

The US Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the Roche's cobas Strep A test for use on the cobas Liat System. It is the first CLIA ...
Nasdaq

Roche's 4-in-1 Test For COVID, Flu, RSV Gets FDA Emergency Use Nod

(RTTNews) - Roche (RHHBY) said that the U.S. Food and Drug Administration has granted Emergency Use Authorization for its cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated ...
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 ...
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 ...
Business Insider

Roche receives FDA clearance for Factor II and Factor V test on the cobas® 4800 system

PLEASANTON, Calif., Feb. 13, 2018 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA clearance for the cobas® Factor II and Factor V Test for use on the cobas® ...
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 Business Journals

Alere says new molecular strep test works twice as fast as Roche's

Alere i Strep A test is more accurate than existing lateral flow tests for strep, and is now the fastest test on the market, delivering results in just 8 minutes. Diagnostics firm Alere announced ...
Yahoo News UK

Quick flu test tipped to save NHS in England £24m a year

The virus affects up to 10% of adults and as many as 30% of children each year, peaking between January and March. The virus affects up to 10% of adults and as many as 30% of children each year, ...
Business Insider

Roche receives FDA clearance to expand testing menu on cobas 6800/8800 Systems for sexually transmitted diseases

PLEASANTON, Calif., May 23, 2019 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) 510(k) clearance for the cobas® TV/MG test for use on the ...