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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hematopoietic cell enrichment kit
Definition A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow.
Product CodeQYO
Regulation Number 866.6120
Device Class 2


Premarket Reviews
ManufacturerDecision
STEMCELL TECHNOLOGIES CANADA INC.
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