DeviceClearance

Product code NSU— Clinical Chemistry

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

Classification name
Instrumentation For Clinical Multiplex Test Systems
Device class
Class 2
Regulation
21 CFR 862.2570
Advisory panel
Clinical Chemistry
Total cleared
13
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code NSU under 21 CFR 862.2570, via openFDA

Market context for product code NSU

FDA has cleared 13 devices under product code NSU between 2004 and 2017, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NSU

Recent clearances under product code NSU

Data sourced from openFDA. This site is unofficial and independent of the FDA.