INTENDED USE - Food and Drug Administration
intended use Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro , visually read, qualitative immunoassay for the simultaneous of Human Immunodeficiency VirusType 1 ( HIV- 1) p24 antigen (Ag ...
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eSubmitter Quick Guide - Food and Drug …
www.fda.govAllows you to create a new submission entry. The New Submission Data Dialog box will ap-pear. See section Creating a New Submission for more detailed information.
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Study Data Specifications - Food and Drug …
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Sanofi Pasteur 20 April 2016v0.2 095 - ActHIB LE6940
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Repackaging of Certain Human Drug Products by …
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POLICY AND PROCEDURES OFFICE OF …
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BIORESEARCH MONITORING TECHNICAL …
www.fda.govBIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE Containing Technical Specifications For questions regarding …
Guidance for Industry - Food and Drug …
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