Performance Evaluation cobas u 701 US
-
- STATUS
- Not Recruiting
Updated on 19 February 2024
Summary
As part of the normal development process in Roche diagnostic each new system must be checked externally. This performance evaluation includes experiments for repeatability, precision, method comparison, assessment of reference range values, etc. The goal of this study is to record the required data for the 510(k) submission to the FDA.
Details
| Condition | Healthy |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX10271 |
| Last Modified on | 19 February 2024 |
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