FDA Product Code OCC: Respiratory Virus Panel Nucleic Acid Assay System

Under FDA product code OCC, respiratory virus panel nucleic acid assay systems are cleared for multiplex detection of respiratory viral pathogens.

These assays simultaneously identify multiple common respiratory viruses — including influenza A/B, RSV, parainfluenza, adenovirus, and human metapneumovirus — from a single respiratory specimen, enabling rapid and comprehensive viral diagnosis for patient cohorting and treatment decisions.

OCC devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Luminex Molecular Diagnostics, Inc., Cepheid and Nanosphere, Inc..