Device typeMultiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to one or multiple species of the rickettsial bacteria associated with spotted fever in a clinical specimen, using an enzyme immunoassay (EIA) method. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis.
FDA categoryREAGENT, RICKETTSIA SEROLOGICAL
Device ID00840239052971
Catalog numberEIA-5297
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information