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

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

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080819.pdf

Dokumentenart:
Guidance for Industry
Inhalt:
Für in vitro diagnostk die zur Untersuchung der Spendertauglichkeit bzgl. Retrioviren eingesetzt wird oder zur Transfusionskompatibilität

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