Roche Molecular Systems, Inc.; Premarket Approval of Roche Amplicor HIV-1 Monitor Test

Samenvatting

The Food and Drug Administration (FDA) is announcing its approval of the application by Roche Molecular Systems, Inc., Somerville, NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Roche Amplicor HIV-1 Monitor Test. After reviewing the recommendation of the Blood Products Advisory Committee (BPAC), FDA's Center for Biologics Evaluation and Research (CBER) notified the applicant, by letter of June 3, 1996, of the approval of the application.