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Title Guidance for industry [electronic resource] : recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from donors of human cells, tissues and cellular and tissue-based products (HCT/Ps)

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2004]
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Connect to https://permanent.fdlp.gov/LPS112939/fda/www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091374.pdf

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:L 11    ---  Available
Description i, 7 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on May 21, 2009).
"November 2004".
Bibliography Includes bibliographical references (p. 7).
Subject Blood -- Examination -- United States.
Cell culture -- United States -- Testing.
Donation of organs, tissues, etc. -- United States -- Testing.
Communicable diseases -- United States -- Prevention.
Added Author Center for Biologics Evaluation and Research (U.S.)
Added Title Recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood specimens from donors of human cells, tissues and cellular and tissue-based products (HCT/Ps)
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:L 11

 
    
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