Food and Drug Administration, HHS § 866.3125

§ 866.3065 Bordetella spp. serological § 866.3110 Campylobacter fetus sero- reagents. logical reagents. (a) Identification. Bordetella spp. sero- (a) Identification. Campylobacter fetus logical reagents are devices that con- serological reagents are devices that sist of antigens and antisera, including consist of antisera conjugated with a antisera conjugated with a fluorescent fluorescent dye used to identify dye, used in serological tests to iden- Campylobacter fetus from clinical speci- tify Bordetella spp. from cultured iso- mens or cultured isolates derived from lates or directly from clinical speci- clinical specimens. The identification mens. The identification aids in the di- aids in the diagnosis of diseases caused agnosis of diseases caused by bacteria by this bacterium and provides epide- belonging to the genus Bordetella and miological information on these dis- provides epidemiological information eases. Campylobacter fetus is a frequent on these diseases. Bordetella spp. cause cause of abortion in sheep and cattle whooping cough (Bordetella pertussis) and is sometimes responsible for endo- and other similiarly contagious and carditis (inflammation of certain mem- branes of the heart) and enteritis (in- acute respiratory infections character- flammation of the intestines) in hu- ized by pneumonitis (inflammation of mans. the lungs). (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). trols). The device is exempt from the premarket notification procedures in § 866.3120 Chlamydia serological re- subpart E of part 807 of this chapter agents. subject to the limitations in § 866.9. (a) Identification. Chlamydia sero- [47 FR 50823, Nov. 9, 1982, as amended at 54 logical reagents are devices that con- FR 25046, June 12, 1989; 66 FR 38791, July 25, sist of antigens and antisera used in se- 2001] rological tests to identify antibodies to chlamydia in serum. Additionally, § 866.3085 Brucella spp. serological re- some of these reagents consist of agents. chlamydia antisera conjugated with a (a) Identification. Brucella spp. sero- fluorescent dye used to identify logical reagents are devices that con- chlamydia directly from clinical speci- sist of antigens and antisera used for mens or cultured isolates derived from serological identification of Brucella clinical specimens. The identification spp. from cultured isolates derived aids in the diagnosis of disease caused from clinical specimens or to identify by bacteria belonging to the genus antibodies to Brucella spp. in serum. Chlamydia and provides epidemiolog- Additionally, some of these reagents ical information on these diseases. consist of antisera conjugated with a Chlamydia are the causative agents of fluorescent dye (immunofluorescent re- psittacosis (a form of pneumonia), agents) used to identify Brucella spp. lymphogranuloma venereum (a vene- directly from clinical specimens or cul- real disease), and trachoma (a chronic tured isolates derived from clinical disease of the eye and eyelid). specimens. The identification aids in (b) Classification. Class I (general con- the diagnosis of brucellosis (e.g., undu- trols). lant fever, Malta fever) caused by bac- § 866.3125 Citrobacter spp. serological teria belonging to the genus Brucella reagents. and provides epidemiological informa- (a) Identification. Citrobacter spp. sero- tion on diseases caused by these micro- logical reagents are devices that con- organisms. sist of antigens and antisera used in se- (b) Classification. Class II (special rological tests to identify Citrobacter controls). The device is exempt from spp. from cultured isolates derived the premarket notification procedures from clinical specimens. The identi- in subpart E of part 807 of this chapter fication aids in the diagnosis of disease subject to § 866.9. caused by bacteria belonging to the [47 FR 50823, Nov. 9, 1982, as amended at 63 genus Citrobacter and provides epide- FR 59226, Nov. 3, 1998] miological information on diseases

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