De-identified residual collection and testing with Genmark's blood culture gram positive and gram negative panels on the ePlex platform (arm 2); Reproducibility study - blood culture gram positive and gram negative panels on the ePlex platform.
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- STATUS
- Not Recruiting
Summary
The purpose of this study is to collect clinical samples in order to establish the analytical and clinical performance characteristics of the GenMark in vitro diagnostic Sample-to-Answer Blood Culture Identification Gram Postitive and Gram Negative Panels, to support regulatory premarket submissions/notifications.
Description
The purpose of this study is to collect clinical samples in order to establish the analytical and clinical performance characteristics of the GenMark in vitro diagnostic Sample-to-Answer Blood Culture Identification Gram Postitive and Gram Negative Panels, to support regulatory premarket submissions/notifications.
Details
| Condition | Healthy |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX5600 |
| Last Modified on | 19 February 2024 |
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