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10th January 2020  Editorial by: Paul Carton

Applied BioCode's Respiratory Pathogen Panel Receives FDA Approval

Applied BioCode has received FDA 510(k) clearance on the BioCode Respiratory Pathogen Panel (RPP) for use on its high-throughput multiplex BioCode MDx-3000 molecular diagnostic system. 

The BioCode® RPP tests nasopharyngeal swabs for 20 of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, Respiratory Syncytial Virus A/B, Parainfluenza virus types 1, 2, 3, and 4, Human Metapneumovirus A/B, Adenovirus, Rhinovirus/Enterovirus, Coronavirus (229E, OC43, HKU1, and NL63), Mycoplasma pneumoniaeChlamydia pneumoniae, and Bordetella pertussis.

The walk-away BioCode® MDx-3000 system, with the capability to process up to 188 samples in an 8-hour shift, is designed for moderate to high volume laboratories to improve lab workflow, reduce labor and cost. It is an alternative to high cost, low throughput cartridge-based molecular test systems. The BioCode® MDx-3000 also offers a User Defined Mode where laboratories can develop their own multiplex assays.

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Date Published: 10th January 2020

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