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Replacement reagents

This article was originally published in The Gray Sheet

Executive Summary

Updated 1Replacement Reagent & Instrument Family Policy Guidance notes that manufacturers "no longer need to submit an add-to-file prior to marketing different reagent/instrument combinations (including new family members) when both have been previously cleared." The December document, which includes replace reagent and instrument terminology and discusses CLIA categorization and special 510(k)s, supersedes a June 1996 guidance (2"The Gray Sheet" Sept. 15, 1997, I&W-4)...
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