Beckman Coulter flow cytometer cleared for diagnostic use in the U.S., China

Beckman Coulter Life Sciences has received FDA approval and an Import Medical Device Registration Certificate from the China Food and Drug Administration for in vitro diagnostic use of the company's Navios flow cytometer.

Content Dam Bow Online Articles 2013 10 Beckmancoulter Web

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

Related: Flow cytometry: Instruments, components, and impact

The flow cytometer 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. Simultaneous identification and enumeration of T, B, and NK lymphocytes in whole blood provides 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, and the system integrates with various automated preparation devices.

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