ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES is an FDA 510(k)-cleared medical device (K982429) manufactured by Zymetx, 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 August 24, 1998. Regulation: 8.