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

FilmArray® 2.0 Instrument

Name: FilmArray® 2.0 Instrument
Brand: FilmArray® 2.0 Instrument

FilmArray 2.0 is an automated laboratory instrument that works with specific reagent panels to detect nucleic acid targets in clinical specimens. A closed reagent pouch contains the…

Registry build 21.09.26

FilmArray 2.0 is an automated laboratory instrument that works with specific reagent panels to detect nucleic acid targets in clinical specimens. A closed reagent pouch contains the materials for sample preparation, amplification and analysis.

The instrument extracts nucleic acids, performs nested multiplex PCR and evaluates the amplified products by DNA melting analysis. Software interprets the measurements and generates a test report.

Listed Item

Refurbished IVD Instrument (FilmArray® 2.0 Instrument).

Pouch and Instrument Operation

Pneumatic bladders and seals move fluids between pouch compartments, while controlled heating and cooling drive the reactions. Fluorescence images provide the analytical signal. Up to eight instruments can connect to one computer for centralized data management, with optional barcode scanning and rack accessories.

9manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

2recalls on this code

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 FilmArray® 2.0 Instrument
Listed by	BioFire Diagnostics, LLC, United States
FDA product code	NSU
Device type	Instrumentation For Clinical Multiplex Test Systems
Device class	Class 2
Regulation	21 CFR 862.2570
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K143178
Record published	2016-09-23
Record revised	2025-07-14 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Distribution end date	2021-06-21

Catalogue Numbers

Catalogue numbers for FilmArray® 2.0 Instrument
Catalogue number	Size	Status
FLM2-ASY-0001		In distribution
FLM2-ASY-0001-W		In distribution
FLM2-ASY-0001		Withdrawn

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
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
FilmArray® Instrument	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
K143178	2015-01-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of FilmArray® 2.0 Instrument
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
BioFire Diagnostics, LLC	510(k) number	2024-08-07	Class II	Under Investigation by firm	Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may	1001

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
2023-10-17	Class II	Device Design	Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power	5,406 systems

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.