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., Hologic, Inc. and Binx Health, Inc..