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Guidance for industry [electronic resource] : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors
Bib ID 4657967
Format BookBook, OnlineOnline
Online Access
Description Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001] 
i, 5 p. : digital, PDF file. 
Technical Details

Mode of access: Internet at the FDA CBER web site. Address as of 5/29/09: http://www.fda.gov/cber/gdlns/bldbrn.pdf ; current access is available via PURL. 

Notes

Title from PDF title page (viewed on May 29, 2009).

"July 2001".

Includes bibliographical references (p. 5).

Subjects Microbiological assay -- Government policy -- United States.  |  Blood donors -- Government policy -- United States.
Other authors/contributors Center for Biologics Evaluation and Research (U.S.)
Also Titled

Revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors

Govt. Doc. Number HE 20.4802:IN 8/3 

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