01731oam 2200421Ia 450 991069813040332120090504150824.0(CKB)5470000002395679(OCoLC)316804441(EXLCZ)99547000000239567920090323d2009 ua 0engurbn|||||||||txtrdacontentcrdamediacrrdacarrierAssay migration studies for in vitro diagnostic devices[electronic resource][Silver Spring, 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 ;Rockville, MD :Center for Biologics Evaluation and Research,[2009]34 pages digital, PDF fileTitle from PDF title page (viewed on Mar. 23, 2009)."January 5, 2009."Includes bibliographical references (page 27).Draft guidance for industry and FDA staffMicrobiological assayFertilization in vitroMedical instruments and apparatusTestingMicrobiological assay.Fertilization in vitro.Medical instruments and apparatusTesting.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.)GPOGPOGPOBOOK9910698130403321Assay migration studies for in vitro diagnostic devices3180071UNINA