What is FDA product code NSU?

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

Clinical Chemistry › Laboratory InstrumentsInstrumentation For Clinical Multiplex Test Systems

Verigene® Processor SP

Name: Verigene® Processor SP
Brand: Verigene® Processor SP

The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a…

Registry build 21.09.26

The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.

9manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NSU
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11
Xian Tianlong Science AND Technology Co., Ltd.	Xi’An	Shaanxi	Manufacturer	8
Xiamen Zeesan Biotech Co., Ltd.	Xiamen	Fujian	Manufacturer	6
Jiangsu Bioperfectus Technologies Co., Ltd.	Taizhou	Jiangsu	Manufacturer	3
Shanghai ZJ BIO-Tech Co., Ltd.	Shanghai	Shanghai	Private-label distributor	3

Record

Regulatory record for Verigene® Processor SP
Listed by	Luminex Corporation, United States
FDA product code	NSU
Device type	Instrumentation For Clinical Multiplex Test Systems
Device class	Class 2
Regulation	21 CFR 862.2570
Establishment	Contract manufacturer, Remanufacturer, Complaint-file establishment, Manufacturer
Record published	2019-12-05
Record revised	2022-09-16 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment temperature -20 to 60 °C

Catalogue Numbers

Catalogue numbers for Verigene® Processor SP
Catalogue number	Size	Status
10-0000-07		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Spartan RX CYP2C19 System	Spartan Bioscience, Inc.	10
BioPlex 2200	Bio-Rad Laboratories Inc.	8
Aptima®	Hologic, Inc.	7
OpsisDx	Entopsis, Inc.	5
Affymetrix	Affymetrix, Inc.	4
FilmArray® 2.0 Instrument Ngds Configuration	BioFire Defense, LLC	3
FilmArray® 2.0 Instrument	BioFire Diagnostics, LLC	3
Opus	Bio-Rad Laboratories Inc.	3
FilmArray® Torch System Base	BioFire Diagnostics, LLC	3
FilmArray® Torch Module	BioFire Diagnostics, LLC	3
Biofire ® Spotfire ® Module	BioFire Diagnostics, LLC	2
Biofire ® Spotfire ® Control Station	BioFire Diagnostics, LLC	2

Showing 12 of 110. All products under Instrumentation For Clinical Multiplex Test Systems

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K133302	2014-01-10
K121399	2013-01-09
K073506	2008-03-07

Recalls Naming This Product

6 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Verigene® Processor SP
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Luminex Corporation	UDI-DI	2021-03-18	Class II	Process control	Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.	1210 Units
Luminex Corporation	UDI-DI	2020-10-13	Class II	Nonconforming Material/Component	Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. The	2838 units	2024-01-22
Luminex Corporation	UDI-DI	2020-10-13	Class II	Nonconforming Material/Component	Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. The	2838 units	2024-01-22
Luminex Corporation	UDI-DI	2020-06-15	Class II	Device Design	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.	Total = 3,016 systems (2240 Verigene Processor SP and 776 Ve	2023-06-30
Luminex Corporation	UDI-DI	2020-06-15	Class II	Device Design	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.	Total = 3,016 systems (2240 Verigene Processor SP and 776 Ve	2023-06-30
Luminex Corporation	UDI-DI	2018-12-10	Class II	Component design/selection	No results/incorrect results due to failure of the hybridization heater.	1 system

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2019-04-22	Class II	Under Investigation by firm	Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.	4 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.