DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA is an FDA 510(k)-cleared medical device (K900604) manufactured by Biovir Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 1990. Regulation: 8.