H-FLU B ELISA TEST

H-FLU B ELISA TEST is an FDA 510(k)-cleared medical device (K831525) manufactured by Seragen Diagnostics, 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 September 28, 1983. Regulation: 8.