LEADER 01468nam 2200373Ia 450 001 9910698821103321 005 20090529140523.0 035 $a(CKB)5470000002397658 035 $a(OCoLC)362359064 035 $a(EXLCZ)995470000002397658 100 $a20090529d2001 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $erevised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2001] 215 $ai, 5 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 29, 2009). 300 $a"July 2001". 320 $aIncludes bibliographical references (page 5). 517 $aGuidance for industry 606 $aMicrobiological assay$xGovernment policy$zUnited States 606 $aBlood donors$xGovernment policy$zUnited States 615 0$aMicrobiological assay$xGovernment policy 615 0$aBlood donors$xGovernment policy 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698821103321 996 $aGuidance for industry$93434577 997 $aUNINA