THYRETAIN TM TSI REPORTER BIOASSAY

THYRETAIN TM TSI REPORTER BIOASSAY is an FDA 510(k)-cleared medical device (K092229) manufactured by Diagnostic Hybrids, 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 May 17, 2010. Regulation: 8.