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T-SPOT®.TB8
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Details
Device typeMycobacterium tuberculosis complex species antigen 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 antigens from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.
FDA categoryMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Device ID15051716000305
Catalog numberTB.300US
MRI safetyLabeling does not contain MRI Safety Information