FDA regulation of analyte-specific reagents (ASRs). Implications for nucleic acid-based molecular testing.
Garrett
C T
CT
Ferreira-Gonzalez
A
A
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
D007202:Indicators and Reagents