Zdrowie i gospodarka · 27/05/2015
FDA Classifies Multiplex Nucleic Acid Assay for Microorganism Identification and Resistance Markers
The FDA has classified a multiplex nucleic acid assay for identifying microorganisms and resistance markers from positive blood cultures into Class II, requiring special controls to ensure the device's safety and effectiveness.
Source: Federal Register — Food and Drug AdministrationOpen original release →