NSU · Class II · 21 CFR 862.2570

FDA Product Code NSU: Instrumentation For Clinical Multiplex Test Systems

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

Leading manufacturers include Luminex Corp., Affymetrix, Inc. and Nanosphere, Inc..

13
Total
12
Cleared
143d
Avg days
2004
Since

FDA 510(k) Cleared Instrumentation For Clinical Multiplex Test Systems Devices (Product Code NSU)

13 devices
1–13 of 13
Cleared Jun 09, 2017
ePlex Instrument
K163652
Genmark Diagnostics, Incorporated
Microbiology · 168d
Cleared Jan 30, 2015
FilmArray 2.0 System
K143178
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Oct 22, 2014
VANTERA CLINICAL ANALYZER
K133849
Liposcience
Chemistry · 307d
Cleared May 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220
Thermo Fisher Scientific (Life Technologies Holdin
Microbiology · 10d
Cleared Jan 10, 2014
FLEXMAP 3D
K133302
Luminex Corp.
Pathology · 77d
Cleared Jan 09, 2013
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
K121399
Luminex Corp.
Immunology · 245d
Cleared Dec 02, 2011
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
K110786
GenMark Diagnostics, Inc.
Chemistry · 255d
Cleared Apr 28, 2010
ILLUMINA BEADXPRESS SYSTEM
K093128
Illumina, Inc.
Hematology · 208d
Cleared Sep 30, 2008
APPLIED BIOSYSTEMS 7500 FAST DX
K082562
Applied Biosystems, Inc.
Microbiology · 26d
Cleared Jul 30, 2008
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
K080995
Affymetrix, Inc.
Chemistry · 114d
Cleared Mar 07, 2008
LUMINEX LX 100/200 INSTRUMENT
K073506
Luminex Corp.
Chemistry · 85d
Cleared Oct 11, 2007
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
K070597
Nanosphere, Inc.
Hematology · 223d
Not Cleared Dec 23, 2004
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
DEN040012
Affymetrix, Inc.
Toxicology · 50d

About Product Code NSU - Regulatory Context