BD’s im­muno­log­i­cal IVD sys­tem gets FDA clear­ance

BioSpectrum (Asia) - - Supplier News -

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.

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