FDA Product Code QQX: Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Under FDA product code QQX, respiratory specimen nucleic acid tests for SARS-CoV-2 are cleared for the molecular diagnosis of COVID-19.
These PCR-based or isothermal amplification assays detect SARS-CoV-2 RNA in nasopharyngeal, nasal, or saliva specimens with high sensitivity and specificity. They are used in clinical laboratories for COVID-19 diagnosis and surveillance.
QQX devices are Class II medical devices, regulated under 21 CFR 866.3981 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Cepheid and Hologic, Inc..
List of Respiratory Specimen Nucleic Acid Sars-cov-2 Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Respiratory Specimen Nucleic Acid Sars-cov-2 Test devices (product code QQX). 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 →