> ## 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.

# Applied BioCode Gains Clearance for Gastro Panel
- URL: https://www.fdaweb.com/applied-biocode-gains-clearance-for-gastro-panel/
- Published: 2019-06-12T12:00:00.000Z
- Updated: 2026-09-15T01:32:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144324

FDA has cleared an Applied BioCode 510(k) to permit the use of Roche’s MagNA Pure 96 Extraction System with the high throughput BioCode MDx-3000 and Gastrointestinal Pathogen Panel (GPP). Previously, BioCode’s devices were cleared for use on bioMerieux’s Nuclisens easyMAG extraction system. Applied BioCode says the MagNA Pure 96 System can extract DNA/RNA from up to 96 patient samples in about 60 minutes. GPP provides results for the 17 most common bacteria, viruses, and parasites that cause infectious diarrhea.