GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC is an FDA 510(k)-cleared medical device (K143592) manufactured by The Surgeon General, Department of the Army. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 2015. Regulation: 8.