
Theratest Laboratories, Inc.
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THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR is an FDA 510(k)-cleared medical device (K972790) 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 December 4, 1997. Regulation: 8.