Definition: An Assay Used To Determine The Level Of Oral Direct Thrombin Inhibitors (DTI) Present In Human Plasma
| Device Type ID | 2512 |
| Device Name | Assay, Oral Direct Thrombin Inhibitor |
| 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 |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | QBG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |