Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents
fda-device · Food and Drug Administration · Rule · Published 2014-09-10 · Effective 2014-10-10 · 79 FR 53608
Document
Document number
2014-21479
Federal Register citation
79 FR 53608
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-09-10
Effective date
2014-10-10
HHS docket
Docket No. FDA-2014-N-1166
Abstract
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.