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Title Assay migration studies for in vitro diagnostic devices [electronic resource].

Imprint [Silver Spring, Md.] : U.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 ; Rockville, MD : Center for Biologics Evaluation and Research, [2009]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:V 83    ---  Available
Description 34 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on Mar. 23, 2009).
"January 5, 2009."
Bibliography Includes bibliographical references (p. 27).
Subject Microbiological assay.
Fertilization in vitro.
Medical instruments and apparatus -- Testing.
Added Author Center for Devices and Radiological Health (U.S.). Office of In Vitro Diagnostic Device Evaluation and Safety.
Center for Biologics Evaluation and Research (U.S.)
Note At head of title: Draft guidance for industry and FDA staff
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:V 83

 
    
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