21 C.F.R. § 866.3305 Herpes simplex virus serological reagents.
Title 21 - Food and Drugs
(a) Identification. Herpes simplex virus serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the reagents consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §866.3. [47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents
§ 866.3305 Herpes simplex virus serological reagents.
