February 2020—Applied BioCode has received FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel for use on the company’s BioCode MDx-3000 system. The panel tests nasopharyngeal swabs for common viruses and bacteria, including influenza A and subtypes H1, H1N1 2009pdm, and H3; influenza B; respiratory syncytial virus A/B; parainfluenza virus types 1–4; human metapneumovirus A/B; adenovirus; rhinovirus/enterovirus; coronavirus (229E, NL63, OC43, and HKU1); Mycoplasma pneumoniae; Chlamydia pneumoniae; and Bordetella pertussis.
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Applied BioCode respiratory pathogen panel gets FDA clearance
Jan. 9, 2020—Applied BioCode has received FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel for use on the company’s BioCode MDx-3000 system.
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