federal_register: 2011-20115

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-20115 Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device Rule The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. 2011-08-09 2011 8 https://www.federalregister.gov/documents/2011/08/09/2011-20115/immunology-and-microbiology-devices-reclassification-of-the-herpes-simplex-virus-serological-assay https://www.govinfo.gov/content/pkg/FR-2011-08-09/pdf/2011-20115.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and...

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