21 C.F.R. § 866.3660 Shigella spp. serological reagents.
Title 21 - Food and Drugs
(a) Identification. Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identify Shigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genus Shigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §866.9. [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents
§ 866.3660
