FDA Product Code OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay
Under FDA product code OZE, influenza A and B multiplex nucleic acid assay systems are cleared for the rapid molecular diagnosis of influenza.
These assays simultaneously detect and differentiate influenza A and influenza B from respiratory specimens using nucleic acid amplification technology, providing results within hours compared to days for viral culture and distinguishing influenza from other respiratory illnesses.
OZE devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Centers For Disease Control and Prevention and Quidel Corporation.
List of Influenza A And Influenza B Multiplex Nucleic Acid Assay devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Influenza A And Influenza B Multiplex Nucleic Acid Assay devices (product code OZE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →