FDA posts new special controls guideline on dengue virus serological reagents

May 30, 2014

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.

Read more

By Prostock-studio on Adobe Stock
adobestock_972416821
By peopleimages.com on Adobe Stock
adobestock_1078291131
ID 23177196 | System © Effectteam | Dreamstime.com
dreamstime_xxl_23177196