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U.S. Department of Health and Human Services

Product Classification

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Device system,concentration,hematopoietic stem cell
Review Panel Hematology
Product CodeMZJ
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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