NSU

13 FDA 510(k) clearances · Product code

FDA profile

Official device name

Instrumentation For Clinical Multiplex Test Systems

Device class

Class II (moderate risk)

Regulation

21 CFR 862.2570

Medical specialty

Clinical Chemistry

FDA definition

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

Adverse events (MAUDE)

2013: 40 · 2014: 30 · 2022: 24 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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