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Automated differential cell counter downclassification to Class II sought by Abbott.

This article was originally published in The Gray Sheet

Executive Summary

AUTOMATED DIFFERENTIAL CELL COUNTER DOWNCLASSIFICATION TO CLASS II is justified by technological advances that have minimized the risks of user infection and improper diagnosis, Abbott Diagnostics argues in a Sept. 21 reclassification petition. Abbott asks FDA to downclassify from Class III to Class II automated differential cell counters (ADCCs) "that use flow-cytometric technology to enumerate abnormal cells of the blood."
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