FDA Approves Gen-Probe's Amplified Mycobacterium Tuberculosis Direct Test

Summary

The US Food and Drug Administration (FDA) has granted premarket approval for Gen-Probe's Amplified Mycobacterium tuberculosis Direct Test (MTD), a diagnostic tool for detecting tuberculosis, following a recommendation from the Microbiology Devices Panel and a review by the Center for Devices and Radiological Health (CDRH).