CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST is an FDA 510(k)-cleared medical device (K901243) manufactured by Cel Labs Pty, Ltd.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 20, 1990. Regulation: 8.