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
Internet:
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