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Radiometer's ABL90 Flex analyser cleared by FDA

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for Radiometer's ABL90 Flex, a point-of-care blood gas analyser. The firm claims that the device is the fastest of its kind – it can deliver results in 35 seconds, which is "about a third of the time" that other analysers take. The system can process up to 44 samples per hour, and measures 16 parameters including blood gases, electrolytes, metabolites and CO-oximetry. It requires 65μl of whole blood and has a footprint "about the area of a sheet of paper". Radiometer (Copenhagen, Denmark) launched ABL90 Flex in certain countries outside the US in April (www.clinica.co.uk, 20 April 2010).

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