1. Biological Effect: Hemocompatibility Tests
2. Turnaround time: 6 weeks
3. Sample Requirements:
30 cm² (test item < 0.5 mm thick);
18 cm² (test item ≥ 0.5 mm thick);
at least 3 test items;
The purpose of the study is to determine the potential for the medical device to activate the Complement system in human plasma. The test item is exposed to human plasma and the concentration of SC5b-9 is then analysed by ELISA. The results after exposure to the medical device are compared with those of negative and untreated controls.