Home » FDA Clears Applied BioCode’s Respiratory Pathogen Diagnostic
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.
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