(a) Identification. Vibrio cholerae serological reagents are devices that are used in the agglutination (an antigen-antibody clumping reaction) test to identify Vibrio cholerae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cholera caused by the bacterium Vibrio cholerae and provides epidemiological information on cholera. Cholera is an acute infectious disease characterized by severe diarrhea with extreme fluid and electrolyte (salts) depletion, and by vomiting, muscle cramps, and prostration. If untreated, the severe dehydration may lead to shock, renal failure, cardiovascular collapse, and death.
(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.