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Réglementation et droit · 06/11/19961 min de lecture
Epitope, Inc.; Premarket Approval of OraSureRegister HIV-1 Western Blot Kit
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Résumé
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.
Langue originale de la source: Federal Register — All DocumentsOuvrir le communiqué original →