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US clears Sysmex' low volume haematology analyser:

This article was originally published in Clinica

Executive Summary

The US FDA has cleared for sale Sysmex America's automated haematology analyser for the low volume clinical setting. The pocH-100i system is a compact complete blood count (CBC) and 3-part differential haematology analyser that provides results comparable to the firm's high-end systems, says the Mundelein, Illinois company, the US headquarters of Japan's Sysmex. It is to be marketed to the clinical laboratories as well as to the physician offices. "The FDA's clearance...paves the way for our company to enter the physician marketplace with a product that has application for the more than 13,000 physician office labs performing non-CLIA waived CBC testing as part of patient care," says Kazuya Obe, Sysmex America's president and CEO.

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