CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Quest Diagnostics announced that its Focus Diagnostics products business has received 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 and 2 Direct molecular test on the 3M Integrated Cycler. The new labeling clearance follows the agency’s de novo clearance and CLIA moderate-complexity categorization of the Simplexa HSV 1 and 2 Direct in March 2014. The FDA cleared the test at that time for use with cerebrospinal fluid from patients suspected of HSV central nervous system infection, including encephalitis.
Focus Diagnostics, 562-240-6500