
Roche Diagnostics
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Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF is an FDA 510(k)-cleared medical device (K221842) 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 December 6, 2022. Regulation: 8.