federal_register: 2010-23639
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-23639 | Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the revised draft guidance document entitled "Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays" that would serve as the special control for the device, if FDA amends the special controls. Because FDA is proposing to amend the special control for this device type, the agency is publishing the proposed rule that designates the revised guidance document as the special control for HSV serological devices. | 2010-09-28 | 2010 | 9 | https://www.federalregister.gov/documents/2010/09/28/2010-23639/immunology-and-microbiology-devices-reclassification-of-the-herpes-simplex-virus-serological-assay | https://www.govinfo.gov/content/pkg/FR-2010-09-28/pdf/2010-23639.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend 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... |