Elecsys Anti-SARS-CoV-2

Elecsys Anti-SARS-CoV-2 is an FDA 510(k)-cleared medical device (K250768) 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 June 9, 2025. Regulation: 8.