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100   $a20090323d2009      ua             0
101 0 $aeng
135   $aurbn|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aAssay migration studies for in vitro diagnostic devices$b[electronic resource]
210  1$a[Silver Spring, Md.] :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety ;$aRockville, MD :$cCenter for Biologics Evaluation and Research,$d[2009]
215   $a34 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Mar. 23, 2009).
300   $a"January 5, 2009."
320   $aIncludes bibliographical references (page 27).
517 1 $aDraft guidance for industry and FDA staff
606   $aMicrobiological assay
606   $aFertilization in vitro
606   $aMedical instruments and apparatus$xTesting
615  0$aMicrobiological assay.
615  0$aFertilization in vitro.
615  0$aMedical instruments and apparatus$xTesting.
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$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698130403321
996   $aAssay migration studies for in vitro diagnostic devices$93180071
997   $aUNINA