federal_register: 2017-00199

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2017-00199 Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens Rule 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. 2017-01-12 2017 1 https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for https://www.govinfo.gov/content/pkg/FR-2017-01-12/pdf/2017-00199.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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