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Thera-Test Laboratories, Inc.
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THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR is an FDA 510(k)-cleared medical device (K092757) manufactured by Thera-Test 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 October 8, 2009. Regulation: 8.