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www.fdanews.com/articles/199118-accelerate-diagnostics-gets-fda-clearance-for-updated-blood-culture-testing-platform
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Accelerate Diagnostics Gets FDA Clearance for Updated Blood Culture Testing Platform

September 18, 2020

The FDA has granted Accelerate Diagnostics 510(k) clearance for an updated version of its PhenoTest blood culture testing system for assessing whether certain antibiotics will work against infections in patients.

The product now features better susceptibility-testing performance for four antibiotics used to treat Pseudomonas aeruginosa, a common pathogen that can cause infections in humans.

The test kit automates blood-sample preparation and delivers results in around seven hours.

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