title: FDA regulation of analyte-specific reagents (ASRs). Implications for nucleic acid-based molecular testing.
authors.forename: C T
authors.initials: CT
authors.lastname: Garrett
authors.forename: A
authors.initials: A
authors.lastname: Ferreira-Gonzalez
mesh_terms: D006801:Humans; D007202:Indicators and Reagents / Q000032:analysis*; D009693:Nucleic Acid Hybridization / Q000379:methods*; D012107:Research Design / Q000331:legislation & jurisprudence*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007202:Indicators and Reagents