FDA Product Code QEP: Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Rapid molecular identification of non-viral pathogens enables targeted antimicrobial therapy. FDA product code QEP covers nucleic acid detection systems for non-viral microorganisms including bacteria, fungi, and parasites.
These PCR-based or hybridization assays detect and identify pathogen-specific nucleic acid sequences from clinical specimens including blood, respiratory samples, and body fluids, providing results faster than conventional culture methods.
QEP devices are Class II medical devices, regulated under 21 CFR 866.3393 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Becton, Dickinson and Company and Hologic, Inc..
List of Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections devices (product code QEP). 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 →