FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY is an FDA 510(k)-cleared medical device (K884047) manufactured by Disease Detection International, 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 March 13, 1989. Regulation: 8.