Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device
other · Food and Drug Administration · Rule · Published 2011-08-09 · Effective 2011-09-08 · 76 FR 48715
Document
Document number
2011-20115
Federal Register citation
76 FR 48715
CFR reference
21 CFR 866
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-08-09
Effective date
2011-09-08
HHS docket
Docket No. FDA-2010-N-0429
Abstract
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.