Elecsys HSV-1 IgG (08948844160)

Elecsys HSV-1 IgG (08948844160) is an FDA 510(k)-cleared medical device (K220923) manufactured by Roche Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2022. Regulation: 8.