FDA clears BD Biosciences flow cytometer for immune deficiency diagnosis
Medical technology company BD Biosciences (Franklin Lakes, NJ) has received FDA clearance for its BD FACSLyric flow cytometer for use with BD Multitest assays for immunological assessment of individuals and patients having or suspected of having immune deficiency.
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The flow cytometer, which was CE-Marked to the EU IVD Directive in 2016, combines a benchtop-sized instrument with software, reagents, and services to provide clinicians and scientists with accurate, reliable, and repeatable results.
The flow cytometer supports the BD Multitest four-color assays and six-color TBNK assay, which are flow-based in vitro diagnostic (IVD) assays. These tests determine the percentages and absolute counts of T, B, and natural killer (NK) cells, as well as the CD4 and CD8 subsets of T cells. Together, these metrics can be used in the immunological assessment of individuals and patients having, or suspected of having, immune deficiency. The flow cytometer is available in four configurations to provide laboratories with the flexibility to adapt to changing clinical needs. More IVD assays will be added as they become available.
The flow cytometer is available as an IVD instrument in the U.S., Europe, and other geographies.
For more information, please visit www.bdbiosciences.com.