01486nam 2200349Ia 450 991069889050332120090505161406.0(CKB)5470000002396957(OCoLC)320270493(EXLCZ)99547000000239695720090505d2007 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry and FDA staff[electronic resource] commercially distributed analyte specific reagents (ASRs), frequently asked questionsRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety :Center for Biologics Evaluation and Research,[2007]13 pages digital, PDF fileTitle from PDF title page (viewed on May 5, 2009)."Document issued on: September 14, 2007".Guidance for industry and FDA staff Biological reagentsBiological reagents.Center for Devices and Radiological Health (U.S.).Office of In Vitro Diagnostic Device Evaluation and Safety.Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910698890503321Guidance for industry and FDA staff3451983UNINA