Zdrowie i gospodarka · 02/01/2009

FDA Classifies Enterovirus Nucleic Acid Assay into Class II Special Controls

The FDA is classifying the enterovirus nucleic acid assay into Class II special controls to ensure the device provides a reasonable assurance of safety and effectiveness, with a guidance document titled 'Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA' available for reference.