BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST is an FDA 510(k)-cleared medical device (K902662) manufactured by Baxter Healthcare Corp. 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 30, 1990. Regulation: 8.