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FDA Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This document is intended for use by those firms which manufacture any licensed in vitro diagnostics used to screen donor blood, determine donor suitability, test for retroviral infection, or determine transfusion compatibility.

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