CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY is an FDA 510(k)-cleared medical device (K951059) manufactured by Ciba Corning Diagnostics Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 18, 1995. Regulation: 8.