Roche MRSA/SA Assay Gains 510(k) Clearance | GenomeWeb

NEW YORK (GenomeWeb) – Roche today said that the US Food and Drug Administration cleared the cobas MRSA/SA test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus directly from nasal specimens. 

The PCR-based assay detects both bacteria directly from a single specimen and is for use on the automated cobas 4800 system, Roche said, adding that the approach requires less hands-on time and helps laboratories to reduce costs and improve turnaround time. 

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