58abf7ef-08a5-4ba5-a233-2cff6eafe09aUpdatePublished32018-07-062016-09-16In Commercial Distribution04987270226964PrimaryGS1Beckman Coulter PK TP System226964PH3000710873907FUJIREBIO INC.1falsefalsefalsetruefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse800-223-0125xx@xx.xx800-447-5852xx@xx.xxBK060062061225Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutinationA 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 an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.falseActiveKSZSystem, Test, Automated Blood Grouping And AntibodyDevice Size Text, specifySize Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = TestsStorage Environment TemperatureHandling Environment Temperaturefalsefalse