ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST

ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST is an FDA 510(k)-cleared medical device (K853738) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 5, 1985. Regulation: 8.