This study is currently not recruiting participants.

External Evaluation of HemosIL AcuStar HIT-Ab HemosIL AcuStar HIT0IgG and HemosIL AcuStar HIT controls

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: 100 years or below
  • Gender: All
Updated on 19 Sep 2014. Study ID: 1408829405

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