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test systems / biological products / in-house protocol / similar device / state law / medical devices / blood products / predicate device / insurance purposes using protocols / manufacturing practices / chemical reagent / chemical reaction / manufacturers distributing devices / toxicology test systems / blood banking tests / device manufacturers / isotonic solutions / manufacturing practices.24 / chemical suppliers / chemical substance / individual chemical substance / manufacturing quality control / medical-device manufacturers / laboratory services / tissue processing reagents / insurance risk assessment / gene-expression-profiling test systems / moderate-risk devices / /
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Sara Beardsley / Aruna Prabhala / Benjamin A. Goldberger / Mark McClellan / Mary K. Pendergast / Kathy Hudson / Steven Gutman / Purpose Reagents / Shawna Williams / Dennis Smith / Rick Borchelt / Sharon Terry / Jeffrey N. Gibbs / Gail H. Javitt / Randy J. Prebula / Peter Lurie / Jeffrey K. Shapiro / /
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diagnostic tests / antibodies / in-house protocol / html / Human Genome / pdf / insurance purposes using protocols / DNA Chip / Gene Expression / http / Genotype / /
FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products In Search of a