federal_register: 2014-11635
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-11635 | Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens | Proposed Rule | 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. | 2014-05-22 | 2014 | 5 | https://www.federalregister.gov/documents/2014/05/22/2014-11635/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for | https://www.govinfo.gov/content/pkg/FR-2014-05-22/pdf/2014-11635.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |