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Medicine / Blood products / Biology / Blood / Blood transfusion / Fresh frozen plasma / Whole blood / Leukoreduction / Blood plasma / Anatomy / Transfusion medicine / Hematology


FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MEMORANDUM From:
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Company

IgG / Hemerus Medical LLC / /

Country

United States / /

Event

FDA Phase / Reorganization / /

Facility

Hospital A / Laboratory of Cellular Hematology DH/OBRR/CBER / University of Maryland / /

IndustryTerm

investigational product / red blood cell additive solution / /

MedicalTreatment

leukocyte reduction filtration / liver transplant / surgery / /

Organization

Hoxworth Blood Center / FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MEMORANDUM From / University of Maryland / Laboratory of Cellular Hematology DH/OBRR/CBER / FDA / Army / Centers for Disease Control and Prevention / /

Person

Ping He / Jaro Vostal / /

Position

Medical Officer / Chief / /

Product

SDP / HFM-335 / LEUKOSEP® HWB / PC387580 / SOLX® System / SOLX / LEUKOSEP / /

ProvinceOrState

Maryland / Prince Edward Island / Indiana / /

Technology

leukoreduction / transplantation / /

SocialTag