title: FDA issues final rule for classification and reclassification of immunochemistry reagents and kits.
authors: C R
authors: CR
authors: Taylor
mesh_terms: 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
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic