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U.S. Department of Health and Human Services

Product Classification
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Device kit, cord blood collection
Review Panel Hematology
Product CodeMYK
Premarket Review Center for Biologics Evaluation & Research (CBER)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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