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ANALYTE SPECIFIC REAGENTS USED IN GENETIC TESTS WARRANT CLASS III STATUS, HRG CONTENDS; FDA REGULATION OF IN-HOUSE LAB TESTS URGED

This article was originally published in The Gray Sheet

Executive Summary

Analyte specific reagents used in genetic testing should be regulated as Class III products, Public Citizen's Health Research Group says in June 12 comments on FDA's proposed classification regulation on ASRs.
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