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Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry
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August 14, 2008 Approval Letter
August 14, 2008 Our STNs: Please see table below. Biotest Medical Diagnostics GmbHAttention: Dr. Rolf VornhagenIndustriestrasse 1D-63303 DreieichGERMANY Dear Dr. Vornhagen: We have approved your biologics license applications for the products listed below effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Reagent Red Blood Cells and Reagent…
RotaTeq
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Rhophylac
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OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents
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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
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Decavac
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Smallpox (Vaccinia) Vaccine, Live
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ORTHO T. cruzi ELISA Test System
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