PREMIER-CRYPTOCOCCAL ANTIGEN

PREMIER-CRYPTOCOCCAL ANTIGEN is an FDA 510(k)-cleared medical device (K904393) manufactured by Meridian 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 January 24, 1991. Regulation: 8.