STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K874438) manufactured by Baxter Healthcare 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 January 20, 1988. Regulation: 8.