510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NSUClass II

Instrumentation For Clinical Multiplex Test Systems

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

NSU is the FDA product code for Instrumentation For Clinical Multiplex Test Systems, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "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...". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
NSU
Device name
Instrumentation For Clinical Multiplex Test Systems
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
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
14

Clearances, product code NSU

By decision year
13 clearances under product code NSU with a decision year between 2004 and 2017, 2008 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NSU by decision year
YearClearances
20041
20071
20083
20101
20111
20131
20143
20151
20171

Applicants with the most clearances

Product code NSU
Applicants holding the most 510(k) clearances under product code NSU
ApplicantClearances
Luminex Corporation4
Affymetrix Inc2
Applied Biosystems1
BioFire Diagnostics, LLC1
Genmark Diagnostics, Inc.1
Genmark Diagnostics, Incorporated1
Illumina, Inc.1
Liposcience1
Thermo Fisher Scientific (Life Technologies Holdin1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order