PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY

PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY is an FDA 510(k)-cleared medical device (K920302) manufactured by Gen-Probe, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 5, 1994. Regulation: 8.