ce567422-3cf8-4bb4-ad7b-de1ca5e86413UpdatePublished32018-07-062016-09-16In Commercial Distribution04987270235041PrimaryGS1Lumipulse G TP-N Immunoreaction Cartridges Set235041710873907FUJIREBIO INC.1falsefalsefalsetruefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse610-240-3800customersupport@fdi.comK15314500059861Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.falseActiveLIPEnzyme Linked Immunoabsorption Assay, Treponema PallidumDevice Size Text, specifySize Type = Units per kit; Units = 2; Unit of Measure = 2mLDevice Size Text, specifySize Type =Tests Per Kit; Size Unit = 42; Unit of Measure = TestsSpecial Storage Condition, Specifyright side up with care; no vibrationStorage Environment TemperatureHandling Environment Temperaturefalsefalse