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Transplantation medicine / Stem cells / Transfusion medicine / CD34 / Myeloid leukemia / Hematopoietic stem cell transplantation / Hematopoietic stem cell / Apheresis / Genous / Medicine / Biology / Hematology


SUMMARY OF SAFETY AND PROBABLE BENEFIT I. GENERAL INFORMATION Device Generic Name:
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City

Cologne / Cambridge / /

Company

EMC / Manufacturer’s Working Cell / Miltenyi Biotec Inc. / Baxter Healthcare Corporation / Master Cell Bank / /

Continent

Europe / /

Country

Belarus / Germany / Ecuador / Uruguay / Saudi Arabia / Oman / Mexico / Iran / Kuwait / Chile / Peru / Egypt / Thailand / Malaysia / Russia / United States / Brazil / Syria / Canada / Australia / Columbia / Korea / Singapore / Israel / Argentina / India / /

Event

FDA Phase / /

Facility

Laboratory Use / Corporate Headquarters / /

IndustryTerm

cell bank / saline solution / leukapheresis products / software-controlled instrument / system processing / human leukapheresis products / manufacturing processes / in vitro processing / treatment of Acute Myeloid Leukemia / colloidal solution / Software validation / validation protocols / treatment of patients with acute myeloid leukemia / /

MedicalCondition

another cancer / serious opportunistic viral infections / sterility / metastasis / Hypersensitivity Reactions Hypersensitivity / chronic graft / anaphylaxis / hypersensitivity / post-transplant lymphoproliferative disorder / disease / Acute Intravenous Irritation / host disease / secondary infections / irritation / acute myelogenous leukemia / infectious disease / Acute Myeloid Leukemia / host disease Chronic / transplantation Viral infections / blood disorder / /

MedicalTreatment

radiation therapy / leukapheresis / chemotherapy / Apheresis / remission induction / /

Organization

TÜV Product Service of Munich / Regulatory Affairs Office / TÜV Rheinland Product Service / Intravenous administration / FDA / Advisory Committee / /

Position

General / SAFETY AND PROBABLE BENEFIT I. GENERAL INFORMATION Device Generic Name / /

Product

cyclosporine / cytarabine / CD34 / /

ProvinceOrState

California / Massachusetts / /

Technology

radiation / antibodies / transplantation / chemotherapy / pre-defined validation protocols / /

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