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Zdrowie i gospodarka · 20/10/2017

FDA Classifies Device to Detect Microbial Pathogens in Cerebrospinal Fluid into Class II with Special Controls

The FDA is classifying a device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into Class II with special controls, aiming to enhance patient access to innovative devices while ensuring safety and effectiveness

Source: Federal Register — Food and Drug AdministrationOpen original release →