FDA Clears Applied BioCode’s Respiratory Pathogen Diagnostic

The FDA granted Applied BioCode 510(k) clearance for its BioCode respiratory pathogen panel, a diagnostic test used with its MDx-3000 system for detecting common respiratory viruses and bacteria.

The test uses nasopharyngeal swabs to detect Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, Respiratory Syncytial Virus A/B, Parainfluenza virus types 1, 2, 3, and 4, Adenovirus, Rhinovirus/Enterovirus and others.

The MDx-3000 system is capable of processing up to 188 samples in an eight hour shift and is designed for use in moderate to high volume laboratories.