DIRECT FLUORESCENT ANTIBODY KIT/HERPES

DIRECT FLUORESCENT ANTIBODY KIT/HERPES is an FDA 510(k)-cleared medical device (K802590) manufactured by Bartels & Stout, 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 February 8, 1981. Regulation: 8.