Epitope, Inc.; Premarket Approval of OraSureRegister HIV-1 Western Blot Kit

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The Food and Drug Administration (FDA) is announcing its approval of the application submitted by Epitope, Inc., Beaverton, OR, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the OraSure HIV-1 Western Blot Kit. FDA's Center for Biologics Evaluation and Research (CBER) notified the applicant, by letter of June 3, 1996, of the approval of the application.