
bioMerieux, Inc.
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VIDAS TBI (GFAP, UCH-L1) is an FDA 510(k)-cleared medical device (K240279) manufactured by bioMerieux, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2024. Regulation: 8.