Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens
Information
Type
Proposed Rule
Regulated products
Published
May 22, 2014
Last updated
May 22, 2014
Description
Document number 2014-11635. The Food and Drug Administration (FDA) is proposing to reclassify 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)