Applied BioCode Cleared to Market New Diagnostic Device

The FDA granted 510(k) clearance to Applied BioCode’s MDx3000 high-volume molecular diagnostic device that can detect 17 types of gastrointestinal pathogens, bacteria, parasites and viruses.

The system is based on Applied BioCode's barcoded magnetic beads technology which offers up to 4,096 different barcoded patterns. Up to 100 different barcodes per assay can be run on the device.

Up to 94 patient samples can be completed on the system in less than five hours.