(CercleFinance.com) – Roche announces that the United States Food and Drug Administration (FDA) has granted 510(k) clearance to its cobas SARS-CoV-2 Qualitative PCR test for use on cobas fully automated systems 6800 and 8800.
“This stand-alone test is intended for the qualitative detection of the virus causing Covid-19, in nasal and nasopharyngeal samples from symptomatic patients suspected of having the disease”, specifies the Swiss health group.
This authorization will ensure that healthcare professionals in the United States will have access to ‘fast, reliable and accurate’ Covid-19 PCR tests beyond the period of emergency use authorization, which has been granted to cobas SARS-CoV-2 in March 2020.
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