CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI is an FDA 510(k)-cleared medical device (K812188) manufactured by American Scientific Products. 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 30, 1981. Regulation: 8.