ORTHO T. CRUZI ELISA TEST SYSTEM

ORTHO T. CRUZI ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K072732) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 14, 2009. Regulation: 8.