OOI

Real Time Nucleic Acid Amplification System

Product code

OOI

Device name

Real Time Nucleic Acid Amplification System

Device class

Class 2

21 CFR

21 CFR 862.2570

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

14 (all years; only the last 3 years are listed here)

FDA classification definition

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-03-20.

1 summaries are archived here for direct download.