Elecsys Phospho-Tau (181P) Plasma

Elecsys Phospho-Tau (181P) Plasma is an FDA 510(k)-cleared medical device (K252163) manufactured by Roche Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2025. Regulation: 8.