Regulacje i polityka gospodarcza · 6.11.1996

Direct Access Diagnostics; Premarket Approval of ConfideRegister HIV Testing Service Using Dried Blood Spots

The Food and Drug Administration (FDA) is announcing its approval of the application by Direct Access Diagnostics, Bridgewater, NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Confide HIV Testing Service Using Dried Blood Spots (Confide HIV Testing Service). After reviewing the recommendation of the Blood Products Advisory Committee, FDA's Center for Biologics Evaluation and Research (CBER) notified the applicant, by letter of May 14, 1996, of the approval of the application.