FDA
Top Five Articles on 360Dx Last Week: FDA Authority Over LDTs; Abbott and Trump's Tariffs; More
Last week, readers were most interested in a story about how the FDA could exert authority over LDTs in the future.
Diasorin Nabs FDA 510(k) Clearance for Gram-Negative Bloodstream Infection Panel
The firm's Liaison Plex Gram-Negative Blood Culture Assay is used for the identification of 19 Gram-negative bacteria and eight resistance genes.
Beckman Coulter, Siemens Healthineers, Abbott, Others Gain 510(k) Clearances in March
The US Food and Drug Administration granted clearances for testing instruments, a blood clot drug companion diagnostic test, and infectious disease tests, among other devices.
The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.
Top Five Articles on 360Dx Last Week: FDA LDT Rule Overturned in Court; More
Last week, readers were most interested in a story about the overturning by a federal court of the FDA's LDT rule.
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