Instrumentation for Clinical Multiplex Test Systems

What Is This Device?

Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.

This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

How Is NSU Classified?

Instrumentation For Clinical Multiplex Test Systems is FDA product code NSU, Class 2, 21 CFR 862.2570.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 14 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Use error (3), Process control (2) and Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.