FDA Product Code OOI: Real Time Nucleic Acid Amplification System
Real-time nucleic acid amplification systems provide rapid, instrument-based molecular testing at the point of care. FDA product code OOI covers clinical multiplex real-time PCR instrument systems.
These integrated platforms perform nucleic acid extraction and amplification in a closed cartridge system, delivering results for multiple targets within 1-2 hours directly in clinical laboratories, emergency departments, and point-of-care settings.
OOI devices are Class II medical devices, regulated under 21 CFR 862.2570 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Meridian Bioscience, Inc..
List of Real Time Nucleic Acid Amplification System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Real Time Nucleic Acid Amplification System devices (product code OOI). 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 →