Spotted Fever Group Cf Antigen Suppliers
www.cdc.gov | Send Inquiry | Phone: +1-(888)-232-6348
FDA Registration: 1050190 Employee Count: ~180
Products: Healthcare Service, Arizona Spp Antiserum (FDA Code: GTE), Fluorescent B. Pertussis Antisera (FDA Code: GOZ), Brucella Spp Agglutination Antigen (FDA Code: GSO), Escherichia Coli Antisera (FDA Code: GNA), Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN), ...
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Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae 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).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.
