Navios flow cytometer cleared for diagnostic use in U.S. and China

Oct. 10, 2013

Beckman Coulter Life Sciences has received 510(k) clearance from the U.S. Food and Drug Administration and an Import Medical Device Registration Certificate from the China Food and Drug Administration for the in vitro diagnostic use of the Navios flow cytometry system. In the U.S., the Navios flow cytometer is intended for immunophenotyping in conjunction with proprietary Navios tetra software and CYTO-STAT tetraCHROME reagents.

The Navios has additional capabilities to meet expanded research needs. It incorporates 12 detectors—10 fluorescence detectors and two light scattering detectors. Simultaneous measurements of integral, peak, and width are available for all scatter measurements and up to 10 fluorescent parameters.

Other features include ready to use, pre-optimized CYTO-STAT tetraCHROME reagents and a no-wash protocol to reduce sample handling and enhance laboratory safety. Beckman Coulter’s Navios tetra system, for simultaneous identification and enumeration of T, B, and NK lymphocytes in whole blood, provides a solution for multicolor flow cytometric analysis of lymphocyte subsets as well as CD4+ and CD8+ T cell subsets ratios. Navios software reports cellular characteristics such as size, granularity, and phenotype and combines data in an automated, customized report with plots and formulas. A variety of reporting options are available. Learn more about Beckman Coulter flow cytometers.