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Food and Drug Administration / Medical device / Medical equipment / Medical technology / Premarket approval / Separator / Apheresis / Blood donation / Federal Food / Drug / and Cosmetic Act / Medicine / Transfusion medicine / Hematology


Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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City

Rockville / /

Facility

Rockville Pike / /

IndustryTerm

automated blood cell separator device / device / blood cell separator devices / Internet athttp /

MedicalCondition

injury / seizures / operator infection / shock / cardiac arrhythmias / tetany / thrombosis / air embolism / serious injuries / infectious disease / sepsis / /

MedicalTreatment

apheresis / /

Organization

FDA / U.S. Department of Health and Human Services / Food and Drug Administration Center for Biologics Evaluation and Research / office of Communication / Outreach and Development / office of Management and Budget / U.S. Department of Health / /

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ProvinceOrState

Maryland / /

URL

www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati / /

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