Roche's cobas SARS-CoV-2 Test Receives the US FDA's Emergency Use Authorization to Identify Corona Virus
Shots:
- The US FDA has issued a EUA for Roche’s cobas SARS-CoV-2 test for the qualitative detection of SARS-CoV-2- in nasopharyngeal and oropharyngeal swab samples taken from patients who meet COVID-19 clinical/ epidemiological criteria for testing
- The CE-IVD test is available in markets accepting the CE mark for patients with signs and symptoms of COVID-19. The CE mark and FDA’s EUA allow patients to access the diagnostic test to combat the disease
- The cobas SARS-CoV-2 test can be run on Roche’s cobas 6800/ 8800 systems and provide results in 3.5hrs.- offering operating efficiency & fastest time-to-results with the highest throughput providing ~96 results in ~3hrs. and a total of 1-440 results for the cobas 6800 system and 4-128 results for the cobas 8800 system in 24hrs.
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