FDA issues final rule for classification and reclassification of immunochemistry reagents and kits.
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D006801:Humans; D007150:Immunohistochemistry / Q000145:classification*; D007202:Indicators and Reagents / Q000145:classification*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic