Theranos Herpes Simplex Virus-1 IgG Assay

Theranos Herpes Simplex Virus-1 IgG Assay is an FDA 510(k)-cleared medical device (K143236) manufactured by Theranos, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2015. Regulation: 8.