Medical Device Network on MSN

Roche’s test for Bordetella infections gains FDA clearance

Roche’s point-of-care polymerase chain reaction (PCR) test for pertussis (whooping cough) and other Bordetella infections has ...

Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and ...
Fierce Biotech

Roche's point-of-care whooping cough test greenlighted in US, Europe as cases surge

Designed for use in doctor’s offices, clinics and emergency rooms, the PCR diagnostic aims to deliver results in fewer than ...
PMLive

Roche receives FDA clearance for whooping cough test

Roche has received clearance from the US Food and Drug Administration (FDA) for its point of care diagnostic test for ...
TipRanks on MSN

Roche receives FDA clearance with CLIA waiver for pertussis point-of-care test

Roche (RHHBY) announced that its first point-of-care test for the diagnosis of whooping cough, or pertussis, and other Bordetella infections, has ...
Medical Dialogues

USFDA clears Roche 15-minute Bordetella PCR Test

Basel: Roche has announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other ...
WDAF-TV

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

PLEASANTON, Calif., Feb. 23, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of the COVID-19 PCR portfolio to the cobas Ⓡ 5800 System, a recently launched ...
BioWorld

Roche launches breakthrough 12-target PCR test

Roche AG’s new test using its temperature-activated generation of signal technology is the next step in PCR evolution, Igor Kozlov, head of Reagent Research and Design at Roche Diagnostics Solutions, ...
Nasdaq

Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases

Roche to acquire the TIB Molbiol Group with the expectation to close in fourth quarter of 2021 TIB Molbiol excels in ultra-rapid assay development for emerging infectious disease, strongly ...
Nasdaq

Roche Gets FDA Clearance For COVID-19 PCR Test For Use On Automated Cobas 6800/8800 Systems

(RTTNews) - The U.S. Food and Drug Administration has granted 510(k) clearance for the cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and cobas 8800 Systems, Swiss ...