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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

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.