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U.S. Department of Health and Human Services

Product Classification
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Device test, ecarin clotting time (ect)
Review Panel Hematology
Product CodeNDV
Submission Type HDE
Device Class 3 (De Novo Petitions Granted)
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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