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Office of the Surgeon General, U.S. Army
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GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS is an FDA 510(k)-cleared medical device (K051794) manufactured by Office of the Surgeon General, U.S. 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 August 15, 2005. Regulation: 8.