Food and Drug Administration, HHS § 866.3400

are associated with inflammatory con- specimens. The identification aids in ditions of the urinary and respiratory the diagnosis of disease caused by bac- tracts, the genitals, and the mouth. teria belonging to the genus Neisseria, The effects in humans of infection with such as epidemic cerebrospinal menin- Mycoplasma pneumoniae range from gitis, meningococcal disease, and gon- inapparent infection to mild or severe orrhea, and also provides epidemiolog- upper respiratory disease, ear infec- ical information on diseases caused by tion, and bronchial pneumonia. these microorganisms. The device does (b) Classification. Class I (general con- not include products for the detection trols). The device is exempt from the of gonorrhea in humans by indirect premarket notification procedures in methods, such as detection of anti- subpart E of part 807 of this chapter bodies or of oxidase produced by gono- subject to § 866.9. coccal organisms. (b) Classification. Class II (perform- [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000] ance standards).

§ 866.3380 Mumps virus serological re- § 866.3395 Norovirus serological re- agents. agents. (a) Identification. Mumps virus sero- (a) Identification. Norovirus sero- logical reagents consist of antigens and logical reagents are devices that con- antisera used in serological tests to sist of antigens and antisera used in se- identify antibodies to mumps virus in rological tests to detect the presence of serum. Additionally, some of these re- norovirus antigens in fecal samples. agents consist of antisera conjugated These devices aid in the diagnosis of with a fluorescent dye norovirus infection in the setting of an (immunofluorescent reagents) used in individual patient with symptoms of serological tests to identify mumps vi- acute gastroenteritis when the indi- ruses from tissue culture isolates de- vidual patient is epidemiologically rived from clinical specimens. The linked to other patients with symp- identification aids in the diagnosis of toms of acute gastroenteritis and/or mumps and provides epidemiological aid in the identification of norovirus as information on mumps. Mumps is an the etiology of an outbreak of acute acute contagious disease, particularly gastroenteritis in the setting of in children, characterized by an en- epidemiologically linked patients with largement of one or both of the parotid symptoms of acute gastroenteritis. glands (glands situated near the ear), (b) Classification. Class II (special although other organs may also be in- controls). The special control is FDA’s volved. guidance document entitled ‘‘Class II (b) Classification. Class I (general con- Special Controls Guidance Document: trols). The device is exempt from the Norovirus Serological Reagents.’’ See premarket notification procedures in § 866.1(e) for the availability of this subpart E of part 807 of this chapter guidance document. subject to § 866.9. [77 FR 14274, Mar. 9, 2012] [47 FR 50823, Nov. 9, 1982, as amended at 65 EFFECTIVE DATE NOTE: At 77 FR 14274, Mar. FR 2311, Jan. 14, 2000] 9, 2012, § 866.3395 was added, effective April 9, 2012. § 866.3390 Neisseria spp. direct sero- logical test reagents. § 866.3400 Parainfluenza virus sero- (a) Identification. Neisseria spp. direct logical reagents. serological test reagents are devices (a) Identification. Parainfluenza virus that consist of antigens and antisera serological reagents are devices that used in serological tests to identify consist of antigens and antisera used in Neisseria spp. from cultured isolates. serological tests to identify antibodies Additionally, some of these reagents to parainfluenza virus in serum. The consist of Neisseria spp. antisera con- identification aids in the diagnosis of jugated with a fluorescent dye parainfluenza virus infections and pro- (immunofluorescent reagents) which vides epidemiological information on may be used to detect the presence of diseases caused by these viruses. Neisseria spp. directly from clinical Parainfluenza viruses cause a variety

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