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T.Cell Xtend®
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venepuncture to between 23 and 30 hours post venepuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
Details
Device typeCell centrifugation/density gradient separation reagent IVD: A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.
FDA categoryMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Device ID15051716000022
Catalog numberTTK.610US
MRI safetyLabeling does not contain MRI Safety Information