IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT is an FDA 510(k)-cleared medical device (K882674) manufactured by Icn Immunobiologicals. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 14, 1989. Regulation: 8.