Zdrowie i gospodarka · 02/11/2015
FDA Classifies Gastrointestinal Microorganism Multiplex Assay into Class II with Special Controls
The Food and Drug Administration has classified a multiplex nucleic acid-based assay for detecting gastrointestinal microorganisms into Class II, requiring special controls to ensure the device's safety and effectiveness.
Source: Federal Register — Food and Drug AdministrationOpen original release →