(inflammation of the brain). Neonatal herpes virus infections range from an 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] §866.3320 Histoplasma capsulatum serological reagents. Histoplasma (a) Identification. capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of Histoplasma capsulatum antisera conjugated with а fluorescent dye (immunofluorescent reagents) used to identify Histoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genus Histoplasma and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs. (b) Classification. Class II (performance standards). § 866.3330 Influenza virus serological reagents. (a) Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic. (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] §866.3340 Klebsiella spp. serological reagents. (a) Identification. Klebsiella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), that are used in serological tests to identify Klebsiella spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Klebsiella and provides epidemiological information on these diseases. These organisms can cause serious urinary tract and pulmonary infections, particularly in hospitalized patients. (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] §866.3350 Leptospira spp. serological reagents. (a) Identification. Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Leptospira spp. in serum or identify Leptospira spp. from cultured isolates derived from clinical specimens. Additionally, some of these antisera are conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify Leptospira spp. directly from clinical specimens. The identification aids in the diagnosis of leptospirosis caused by bacteria belonging to the genus Leptospira and provides epidemiological information on this disease. Leptospira infections range from mild fever-producing illnesses to severe liver and kidney involvement producing hemorrhage and dysfunction of these organs. (b) Classification. Class II (performance standards). § 866.3355 Listeria spp. serological reagents. (a) Identification. Listeria spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Listeria spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Listeria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Listeria spp. directly from clinical specimens. The identification aids in the diagnosis of listeriosis, a disease caused by bacteria belonging to the genus Listeria, and provides epidemiological information on diseases caused by these microorganisms. Listeria monocytogenes, the most common human pathogen of this genus, causes meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth. (b) Classification. Class I (general controls). §866.3360 Lymphocytic choriomenin gitis virus serological reagents. (a) Identification. Lymphocytic choriomeningitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to lymphocytic choriomeningitis virus in serum. The identification aids in the diagnosis of lymphocytic choriomeningitis virus infections and provides epidemiological information on diseases caused by these viruses. Lymphocytic choriomeningitis viruses usually cause a mild cerebral meningitis (inflammation of membranes that envelop the brain) and occasionally a mild pneumonia, but in rare instances may produce severe and even fatal illnesses due to complications from cerebral meningitis and pneumonia. (b) Classification. Class I (general controls). § 866.3370 Mycobacterium tuberculosis immunofluorescent reagents. (a) Identification. Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Mycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease. Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung. (b) Classification. Class I (general controls). §866.3375 Mycoplasma spp. serological reagents. a (a) Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated with fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia. (b) Classification. Class I (general controls). § 866.3380 Mumps virus serological reagents. a (a) Identification. Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved. (b) Classification. Class I (general controls). §886.3390 Neisseria spp. direct serological test reagents. (a) Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms. (b) Classification. Class II (performance standards). 866.3400 Parainfluenza virus serological reagents. (a) Identification. Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia. (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] $866.3405 Poliovirus serological reagents. (a) Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity. (b) Classification. Class I (general controls). § 866.3410 Proteus spp. (Weil-Felix) serological reagents. (a) Identification. Proteus spp. (WeilFelix) serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), derived from the bacterium Proteus vulgaris used in agglutination tests (a specific type of antigen-antibody reaction) for the detection of antibodies to rickettsia (virus-like bacteria) in serum. Test results aid in the diagnosis of diseases caused by bacteria belonging to the genus Rickettsiae and provide epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever). (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] §866.3415 Pseudomonas spp. serological reagents. (a) Identification. Pseudomonas spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used to identify Pseudomonas spp. from clinical specimens or from cultured §866.3460 Rabiesvirus immunofluorescent reagents. (a) Identification. Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal. (b) Classification. Class II (performance standards). (a) Identification. Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses. (b) Classification. Class I. These devices are exempt from premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] §866.3480 Respiratory syncytial virus serological reagents. (a) Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia. (b) Classification. Class I (general controls). §866.3490 Rhinovirus serological reagents. (a) Identification. Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rhinovirus in serum. The identification aids in the diagnosis of rhinovirus infections and provides epidemiological information on diseases caused by these viruses. Rhinoviruses cause common colds. (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever). (b) Classification. Class I (general controls). $866.3510 Rubella virus serological reagents. (a) Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome). (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] $866.3520 Rubeola (measles) virus serological reagents. (a) Identification. Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash. (b) Classification. Class I. These devices are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989] §866.3550 Salmonella spp. serological reagents. (a) Identification. Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Salmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genus Salmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever"), severe diarrhea, and cramps. (b) Classification. Class II (performance standards). § 866.3600 Schistosoma spp. serological reagents. (a) Identification. Schistosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Schistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused by parasitic flatworms of the genus Schistosoma. Schistosomiasis is characterized by a variety of acute and chronic infections. Acute infection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver, lungs, and central nervous system. Schistosomes can also cause schistosome dermatitis (e.g., swimmer's itch), a skin disease marked by intense itching. (b) Classification. Class I (general controls). § 866.3630 Serratia spp. serological reagents. (a) Identification. Serratia spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Serratia spp. from cultured isolates. The identification aids in the diagnosis of disease caused by bacteria belonging to the |