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U.S. Department of Health and Human Services

Product Classification
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Device assay, oral direct thrombin inhibitor
Definition An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
Physical State In vitro diagnostic device
Technical Method Coagulometric, clot detection
Target Area Determination of oral direct thrombin inhibitor (DTI) levels in human citrated plasma
Review Panel Hematology
Product CodeQBG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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