Flow Cytometer Cleared for Diagnostic Use in U.S. and China

Beckman Coulter Life Sciences 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. Ready to use, pre-optimized CYTO-STAT tetraCHROME reagents make sample preparation easy. A no-wash protocol reduces sample handling and increases laboratory safety. Beckman Coulter’s Navios tetra system, for simultaneous identification and enumeration of T, B and NK lymphocytes in whole blood, provides an easy-to-use 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 one automated, customized report with plots and formulas. A variety of reporting options are available. Easy integration with a variety of automated preparation devices and LIS-readiness offers secure, high-throughput results, even at the highest volumes.

Beckman Coulter Life Sciences, 800-742-2345, www.beckmancoulter.com