Zdrowie i gospodarka · 22/10/2014
FDA Classifies Nucleic Acid-Based Devices for TB Detection and Antibiotic Resistance
The FDA is classifying nucleic acid-based in vitro diagnostic devices for detecting Mycobacterium tuberculosis complex and antibiotic resistance into Class II, requiring special controls to ensure safety and effectiveness.
Source: Federal Register — Food and Drug AdministrationOpen original release →