Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents
Information
Type
Rule
Regulated products
Medical Devices
Published
September 10, 2014
Last updated
September 10, 2014
Description
Document number 2014-21479. The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)