Dengue Virus Nucleic Acid Amplification Test Reagents: Class II Special Controls Guideline for Industry and Food and Drug Administration Staff
Read the Special Controls Document
Issue Date: 09/10/2014
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
This special controls document was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) nucleic acid amplification test (NAAT) reagents.