This record was last updated November 22, 2024 (before its estimated March 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-01.