Federal Register Final order: FDA is classifying dengue virus nucleic acid amplification test reagents into Class 2 (special controls). The device is assigned the generic name ‘dengue virus nucleic acid amplification test reagents’ and is identified as devices that consist of primers, probes, enzymes, and controls for amplifying and detecting dengue virus serotypes 1, 2, 3, or 4 from viral ribonucleic acid in human serum and plasma from individuals who have signs and symptoms consistent with dengue (mild or severe). To view this final order, click here.