QUANTAI UG REAGENT STRIP

QUANTAI UG REAGENT STRIP is an FDA 510(k)-cleared medical device (K893661) manufactured by Quantai Biotronics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 1989. Regulation: 8.