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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
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible