> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears NeuMoDx’s Group B Strep Assay
- URL: https://www.fdaweb.com/fda-clears-neumodxs-group-b-strep-assay/
- Published: 2018-07-23T12:00:00.000Z
- Updated: 2026-09-15T00:20:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141937

FDA has cleared a NeuMoDx Molecular 510(k) for its NeuMoDx 288 Molecular System and its NeuMoDx GBS \[Group B Streptococcus\] Assay. “The fully automated NeuMoDx 288 Molecular System is the first offering in a family of scalable platforms that integrate the entire diagnostic process – from extraction to detection or ‘sample to result’ – in approximately one hour to first result,” the company says. The device offers the ability to load up to 288 patient samples in a continuous random-access mode resulting in an on-demand, high throughput sample processing workflow with a “true operator walkaway window of more than six hours,” it says. The device’s dry format reagents require no refrigeration and have an on-board stability of greater than 60 days, the company adds.