
Theratest Laboratories, Inc.
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THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS is an FDA 510(k)-cleared medical device (K071692) 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 November 4, 2007. Regulation: 8.