Clinical Utility
The eB-Tchol Blood Total Cholesterol Monitoring System is intended for the quantitative measurement of total cholesterol in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (Over-the-counter [OTC]) by person with hyperlipidemia, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of hyperlipidemia. The test results are plasma calibrated. The measuring range of total cholesterol concentration in capillary whole blood is from 100 to 400 mg/dL (2.6-10.4 mmol/L).
- Model: eB-Tchol Blood Total Cholesterol Monitoring System
- Manufacturer: Visgeneer Inc., Taiwan
- MDA Registration No.: IVDB7996924-182587