LEADER 01486nam 2200349Ia 450 001 9910698890503321 005 20090505161406.0 035 $a(CKB)5470000002396957 035 $a(OCoLC)320270493 035 $a(EXLCZ)995470000002396957 100 $a20090505d2007 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry and FDA staff$b[electronic resource] $ecommercially distributed analyte specific reagents (ASRs), frequently asked questions 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety :$cCenter for Biologics Evaluation and Research,$d[2007] 215 $a13 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 5, 2009). 300 $a"Document issued on: September 14, 2007". 517 $aGuidance for industry and FDA staff 606 $aBiological reagents 615 0$aBiological reagents. 712 02$aCenter for Devices and Radiological Health (U.S.).$bOffice of In Vitro Diagnostic Device Evaluation and Safety. 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698890503321 996 $aGuidance for industry and FDA staff$93451983 997 $aUNINA