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Guidance for industry and FDA staff : commercially distributed analyte specific reagents (ASRs), frequently asked questions.

Bibliographic Details
Corporate Authors: 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.)
Format: Government Document eBook
Language:English
Published: Rockville, 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 : Center for Biologics Evaluation and Research, [2007]
Subjects:
Biological reagents.
Online Access:https://purl.fdlp.gov/GPO/LPS112266
Description
Item Description:Title from PDF title page (viewed on May 5, 2009).
"Document issued on: September 14, 2007".
Electronic resource.
Physical Description:13 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA CBER web site. Address as of 5/05/09: http://www.fda.gov/cdrh/oivd/guidance/1590.pdf ; current access is available via PURL.