MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT is an FDA 510(k)-cleared medical device (K871278) manufactured by California Integrated Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 1987. Regulation: 8.