ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST is an FDA 510(k)-cleared medical device (K993048) manufactured by Roche Diagnostics 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 December 19, 1999. Regulation: 8.