ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. is an FDA 510(k)-cleared medical device (K904047) manufactured by Gen-Probe, 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 October 1, 1990. Regulation: 8.