Gen-ProbeRegister, Inc.; Premarket Approval of Gen- ProbeRegister Amplified Mycobacterium Tuberculosis Direct Test

摘要

The Food and Drug Administration (FDA) is announcing its approval of the application by Gen-Probe , Inc., San Diego, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Gen-Probe Amplified Mycobacterium tuberculosis Direct Test (MTD). After reviewing the recommendation of the Microbiology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter on December 15, 1995, of the approval of the application.