BD’s immunological IVD system gets FDA clearance
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Becton, Dickinson and Company’s (BD) in-vitro diagnostic (IVD) device, FACSLyric flow cytometer system.
The device is cleared for use with BD Multitest assays to immunologically assess patients with or suspected of having an immune deficiency. FACSLyric is a benchtop-sized instrument that works with a combination of software, reagents and services to deliver precise, reliable and repeatable results.
Flow-based IVD assays, BD Multitest 4-Colour and Multitest 6-Colour TBNK that are designed to determine percentages, and absolute counts of T, B, natural killer (NK) cells, and the CD4 and CD8 subsets of T cells will be supported by the new diagnostic system. Available in four configurations, the BD FACSLyric flow cytometer system was CE-Marked last year to the
EU IVD Directive.