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Theratest Laboratories, Inc.
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EL-ACL SCREEN; EL-ACL IGM, IGG, IGA is an FDA 510(k)-cleared medical device (K060176) manufactured by Theratest Laboratories, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2006. Regulation: 8.