Role of the Food and Drug Administration in the use of molecular techniques in immunohematology.
Kochman
Sheryl A
SA
Devices Review Branch, Division of Blood Applications, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA. sheryl.kochman@fda.hhs.gov
D000486:Allergy and Immunology / Q000331:legislation & jurisprudence; D017408:Guidelines as Topic; D006405:Hematology / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D007158:Immunologic Techniques; D025202:Molecular Diagnostic Techniques / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration