{"abstract":"The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/01/23/2014-01216.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"79 FR 3739","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 24, 2014. The classification was effective January 20, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1662"],"dockets":[],"document_number":"2014-01216","effective_on":"2014-02-24","end_page":3740,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/01/23/2014-01216.xml","html_url":"https://www.federalregister.gov/documents/2014/01/23/2014-01216/medical-devices-immunology-and-microbiology-devices-classification-of-john-cunningham-virus","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-01216?publication_date=2014-01-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-01-23/2014-01216/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":197,"last_updated":"2026-07-28 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-23/pdf/2014-01216.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-01216.pdf?1390398806","publication_date":"2014-01-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/01/23/2014-01216.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-1662","supporting_documents_count":0,"docket_id":"FDA-2013-N-1662","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of John Cunningham Virus (JCV) serological reagents","checked_regulationsdotgov_at":"2014-02-12T08:07:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3739,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of John Cunningham Virus Serological Reagents","toc_doc":"Classification of John Cunningham Virus Serological Reagents","toc_subject":"Medical Devices; Immunology and Microbiology Devices:","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":79}