External Evaluation of HemosIL AcuStar HIT-Ab HemosIL AcuStar HIT0IgG and HemosIL AcuStar HIT controls
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- STATUS
- Not Recruiting
Summary
The purpose of this study is to validate the analytical performance of the HemoSIL Acustar - Ab, IgG and controls in a clinical setting and to demonstrate the devices substantial equivalence to a reference method (Serotonin Release Assay) and to demonstrate the device's substantial equivalence to a predicate method (Elisa) to meet an identified user need.
Description
The purpose of this study is to validate the analytical performance of the HemoSIL Acustar - Ab, IgG and controls in a clinical setting and to demonstrate the devices substantial equivalence to a reference method (Serotonin Release Assay) and to demonstrate the device's substantial equivalence to a predicate method (Elisa) to meet an identified user need.
Details
| Age | 100years or below |
|---|---|
| Clinical Study Identifier | TX4200 |
| Last Modified on | 19 February 2024 |
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