Clinical Method Comparison Study for the NeuMoDx Group B Streptococcus (GBS) Assay on the NeuMoDx Molecular System
-
- STATUS
- Not Recruiting
Summary
The purpose of this study is to establish the clinical sensitivity and specificity of the NeuMoDx GBS Test by comparing the results to those produced by the GBS culture processing technique recommended by the published 2010 CDC guidelines to provide data in support of a 510(k) Premarket submission.
Description
The purpose of this study is to establish the clinical sensitivity and specificity of the NeuMoDx GBS Test by comparing the results to those produced by the GBS culture processing technique recommended by the published 2010 CDC guidelines to provide data in support of a 510(k) Premarket submission.
Details
| Condition | Streptococcus |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX7692 |
| Last Modified on | 19 February 2024 |
Similar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.