GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT is an FDA 510(k)-cleared medical device (K962217) 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 November 26, 1996. Regulation: 8.