PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT

PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT is an FDA 510(k)-cleared medical device (K880824) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 11, 1988. Regulation: 8.