FDA Product Code QOF: Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

FDA product code QOF covers multi-target respiratory specimen nucleic acid tests.

These multiplex molecular assays simultaneously detect and identify multiple respiratory pathogens — including influenza A/B, RSV, SARS-CoV-2, and others — from a single patient sample. They provide faster and more comprehensive results than single-target tests, enabling rapid differentiation of respiratory illnesses.

QOF devices are Class II medical devices, regulated under 21 CFR 866.3981 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Biofire Diagnostics, LLC, Roche Molecular Systems, Inc. and Cepheid.