FDA posts new special controls guideline on dengue virus serological reagents

A new guideline, “Class II Special Controls Guideline: Dengue Virus Serological Reagents,” has recently been posted by the FDA. This document was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) serological reagents. DENV serological reagents are devices that consist of antigens and antibodies for the detection of DENV and DEN antibodies in individuals who have signs and symptoms of dengue fever (DF) or dengue hemorrhagic fever (DHF). The detection aids in the clinical laboratory diagnosis of DF or DHF caused by DENV infection. Read the guideline.