Elecsys Anti-SARS-CoV-2 S

Elecsys Anti-SARS-CoV-2 S is an FDA 510(k)-cleared medical device (K252280) 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 April 12, 2026. Regulation: 8.