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FDA expands use of Thermo Fisher's BRAHMS PCT assay

The FDA has given Thermo Fisher Scientific business BRAHMS 510(k) clearance for expanded use of its procalcitonin-sensitive Kryptor assay as a tool for antibiotic stewardship in intensive care, emergency departments and other hospital units. The assay, which was previously cleared for clinical use, is also intended to facilitate clinicians' decision-making on the initiation of antibiotic therapy for patients with confirmed or suspected lower-respiratory-tract infections.

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