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Zdrowie i gospodarka · 10/09/2014

FDA Classifies Dengue Virus Nucleic Acid Amplification Test Reagents into Class II Special Controls

The Food and Drug Administration (FDA) has classified dengue virus nucleic acid amplification test reagents into class II special controls, requiring special controls in addition to general controls to ensure the device's safety and effectiveness.

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