Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens
fda-device · Food and Drug Administration · Rule · Published 2017-01-12 · Effective 2017-02-13 · 82 FR 3609
Document
Document number
2017-00199
Federal Register citation
82 FR 3609
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-01-12
Effective date
2017-02-13
HHS docket
Docket No. FDA-2014-N-0440
Abstract
The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.