TIA-IGG REAGENT & CALIBRATOR SETS

TIA-IGG REAGENT & CALIBRATOR SETS is an FDA 510(k)-cleared medical device (K831101) manufactured by Worthington Diagnostic Systems. 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 26, 1983. Regulation: 8.