0SHBOJ[BUJPO/BNF

/PUF3FQSFTFOUBUJWFTTVCNJUUJOHPOCFIBMGPGBOPSHBOJ[BUJPONVTUFOUFSJOGPSNBUJPOCFMPX

3FRVFTUPS3FQSFTFOUBUJWF

4FDUJPO*OWFTUJHBUJPO$IJOBhT"DUT
1PMJDJFT
BOE1SBDUJDFT3FMBUFEUP5FDIOPMPHZ

5SBOTGFS
*OUFMMFDUVBM1SPQFSUZ
BOE*OOPWBUJPO'PSNUP3FRVFTU&YDMVTJPOPG1SPEVDU

8IFOTVCNJUUJOHBQSPEVDUFYDMVTJPOSFRVFTUVTJOHUIJTGPSN
FOUFSUIFTQFDJGJFE

JOGPSNBUJPOJOUIFGPMMPXJOHGJFMETBOEFYQMBJOUIFCBTJTBOESBUJPOBMFGPSZPVSTUBUFNFOUT

#ZDPNQMFUJOHUIJTGPSN
ZPVDFSUJGZUIBUUIFJOGPSNBUJPOQSPWJEFEJTDPNQMFUFBOE

DPSSFDUUPUIFCFTUPGZPVSLOPXMFEHF

 *OEJDBUFXIFUIFSUIFDPNNFOUDPOUBJOTCVTJOFTTDPOGJEFOUJBMJOGPSNBUJPO	#$*

JTBQVCMJD

EPDVNFOU
PSJTBQVCMJDWFSTJPOPGB#$*EPDVNFOU



 1MFBTFQSPWJEFBDPNQMFUFBOEEFUBJMFEEFTDSJQUJPOPGUIFQBSUJDVMBSQSPEVDUPGDPODFSO





EJHJU)5464JUFNOVNCFSGPSQSPEVDUZPVXJTIUPBEESFTTJOUIJTQSPEVDUFYDMVTJPOSFRVFTU

6TFOVNFSJDBMDIBSBDUFSTPOMZXJUIOPTQFDJBMDIBSBDUFST	FYBNQMF
'PSIFMQJOGJOEJOH

UIF)5464JUFNOVNCFSBTTPDJBUFEXJUIZPVSQSPEVDU
TFFIUUQTIUTVTJUDHPW



 3FRVFTUPShTSFMBUJPOTIJQUPUIFQSPEVDU

 %PFTUIJTTVCNJTTJPOJOSFHVMBUJPOTHPWJODMVEFBEEJUJPOBMBUUBDINFOUT 

1MFBTFJOEJDBUFXIFUIFSBOZBEEJUJPOBMBUUBDINFOUDPOUBJOTCVTJOFTTDPOGJEFOUJBMJOGPSNBUJPO

	#$*

JTBQVCMJDEPDVNFOU
PSJTBQVCMJDWFSTJPOPGB#$*EPDVNFOU

3FRVFTUPS*OGPSNBUJPO

3FRVFTUPS/BNF	-BTU
'JSTU


VERSION 2 CONTINUED BELOW 1

16#-*$46#.*44*0/

Public Version of BCI

Flow cytometry systems composed a flow cytometer analyzer instrument containing one or more lasers 

and silicon photomultiplier detectors, a sampler containing one or more wells or containers, a controlling 

computer pre-configured with flow cytometry software, fluidic stations, fluidic waste bottles, and fluidic 

solutions (provided for under subheading 9027.50.4015, HTSUS). 

For further details regarding the subject flow cytometry system, please see Exhibit A to the attached 

addendum.

9027.50.4015

Wang, Xiaobo

ACEA Biosciences, Inc.

Joseph M. Spraragen

Importer

YES

Public Version of BCI
 *TUIJTQSPEVDU
PSBDPNQBSBCMFQSPEVDU
BWBJMBCMFGSPNTPVSDFTJOUIF6OJUFE4UBUFT 	*GZPV

 *TUIJTQSPEVDU
PSBDPNQBSBCMFQSPEVDU
BWBJMBCMFGSPNTPVSDFTJOUIJSEDPVOUSJFT 	*GZPV

 1MFBTFQSPWJEFUIFWBMVFBOERVBOUJUZ	XJUIVOJUT
PGUIF$IJOFTFPSJHJOQSPEVDUPGDPODFSO

UIBUZPVQVSDIBTFEGPSFBDIDBMFOEBSZFBSTQFDJGJFE-JNJUUIJTGJHVSFUPUIFQSPEVDUT

QVSDIBTFECZZPVSGJSN	PSCZNFNCFSTPGZPVSUSBEFBTTPDJBUJPO
BMPOF1MFBTFQSPWJEF

FTUJNBUFTJGQSFDJTFGJHVSFTBSFVOBWBJMBCMF

7BMVF

7BMVF

7BMVF

2VBOUJUZ

2VBOUJUZ

2VBOUJUZ

PGZPVSUPUBMHSPTTTBMFTJOUIBUUIF$IJOFTFPSJHJOQSPEVDUBDDPVOUFEGPS

PGUIFUPUBMDPTUPGQSPEVDJOHUIFGJOBMQSPEVDU	T
UIF$IJOFTFPSJHJOJOQVU

BDDPVOUTGPS

PGZPVSUPUBMHSPTTTBMFTJOUIBUTBMFTPGUIFGJOBMQSPEVDU	T
JODPSQPSBUJOH

UIFJOQVUBDDPVOUFEGPS

VERSION 2 CONTINUED BELOW 2

JOEJDBUF/0
ZPVNVTUQSPWJEFTVQQPSUGPSZPVSBTTFSUJPOJO#PY


JOEJDBUF/0
ZPVNVTUQSPWJEFTVQQPSUGPSZPVSBTTFSUJPOJO#PY


 *TUIF$IJOFTFPSJHJOQSPEVDUPGDPODFSOTPMEBTBGJOBMQSPEVDUPSBOJOQVUVTFEJO

B
 'PSJNQPSUTTPMEBTGJOBMQSPEVDUT
QMFBTFQSPWJEF

C
 'PSJNQPSUTPGJOQVUTVTFEJOUIFQSPEVDUJPOPGGJOBMQSPEVDUT
QMFBTFQSPWJEF

UIFQSPEVDUJPOPGBGJOBMQSPEVDUPSQSPEVDUT 

16#-*$46#.*44*0/

NO

NO

[ ] [ ]

[ ] [ ]

[ ] [ ]

FINAL PRODUCT

[ ]
 1MFBTFQSPWJEFJOGPSNBUJPOJOTVQQPSUZPVSSFRVFTU
UBLJOHBDDPVOUPGUIF

VERSION 2 &/% 3

JOTUSVDUJPOTQSPWJEFEJO4FDUJPO#PGUIF'FEFSBM3FHJTUFSOPUJDF*GZPV

SFTQPOEFE/0UP2VFTUJPOTPS
ZPVNVTUQSPWJEFTVQQPSUGPSZPVS

BTTFSUJPOJOUIFCPYCFMPX	/PUFUFYUFOUFSFECFMPXDBOFYUFOECFZPOEUIF

BQQBSFOUTJ[FPGUIJTCPY


16#-*$46#.*44*0/

Please see the attached addendum provided in .pdf format.












PUBLIC SUBMISSION

EXHIBIT A 

“NovoCyte Quanteon” 

Flow Cytometry System 
PUBLIC SUBMISSION

Since 2014, over hundreds of Acea NovoCyte branded flow cytometer instruments have been adopted 

by U.S.-based pharmaceutical companies, academic institutions, and government agencies as a powerful 

tool for broad and in-depth cell research applications in curing cancer, understanding the microbiome, 

and safeguarding human health, etc. 

As a part of NovoCyte® branded flow cytometer product family provided by ACEA Biosciences Inc., ACEA 

NovoCyte® QuanteonTM is a 4-laser, up to 25-color flow cytometry analyzer instrument used for 

advanced cell or particle analysis. It enables highly sensitive single cell level, multiparametric analysis of 

millions of cells for a comprehensive view towards hidden yet physiologically relevant cellular and 

molecular events in life sciences. 

The NovoCyte Quanteon instrument is made from metal shell with electronic integrated circuits, fluidic 

tubing, low power lasers (100mW) with optical lenses, etc. It is composed of the optical system, the 

fluidic system, and the electronic system. 

The complete system includes several components below: 

a) flow cytometer instrument with miscellaneous accessories 

b) fluidics station with NovoFlow®, NovoRinse® and NovoClean® and waste fluidic bottles, 

c) the complimentary NovoCyte Quanteon flow cytometer starter kit includes solutions: NovoFlow® 100X 20mL, 

NovoRinse® 1X 500mL, NovoClean® 1X 500mL, NovoCyte® QC Particles 2mL, 

d) controlling computer NovoCyte workstation with NovoExpress® software pre-installed, 

e) automated sampler loader NovoSampler® Q as an optional autosampler accessory to the instrument. 

The size of flow cytometer instrument itself is ~24.4 X 18.1 X 18.8 in (62 X 46 X 48 cm) with weight 

around 104 lbs (47kg). Together with NovoSampler Q, the size is ~33.5 X 18.1 X 18.8 in (85 X 46 X 48 cm) 

with weight around 133 lbs (60 kg). A minimum space of 150 cm (W) × 80 cm (D) × 90 cm (H) is required 

to install the NovoCyte Quanteon instrument and fluidics station. 

The NovoCyte Quanteon flow cytometer is for Research Use Only. Not for use in diagnostic procedures. 
PUBLIC SUBMISSION

Related ACEA Biosciences Product Catalog Number, Model Name, Listing Price, Components

ACEA 

Biosciences 

NovoCyte 

Quanteon 

Product 

Catalogs 

2010097 ACEA NovoCyte QuanteonTM 

4025 Flow Cytometer [ ] Includes Flow Cytometer System, 

Software (total 3 user licenses), 

Workstation, Reagent 

Bottles/Containers, 

Complimentary NovoCyte 

Quanteon Flow Cytometer Starter 

Kit (NovoFlow® Solution 100X 

20mL, NovoRinse® Solution 1X 

500mL, NovoClean® Solution 1X 

500mL, NovoCyte® QC Particles 

2mL), and One-year Warranty. 

2010099 ACEA NovoCyte QuanteonTM 

4020 Flow Cytometer [ ] 

2010100 ACEA NovoCyte QuanteonTM 

4016 Flow Cytometer [ ] 

2010101 

ACEA NovoCyte QuanteonTM 

4000C Customer Build Flow 

Cytometer 

[ ] 

2010098 ACEA NovoCyte QuanteonTM 

4025 Flow Cytometer and 

NovoSampler® Q Combo 

[ ] 

Includes Flow Cytometer System, 

Software (total 3 user licenses), 

Workstation, Reagent 

Bottles/Containers, 

Complimentary NovoCyte 

Quanteon Flow Cytometer Starter 

Kit (NovoFlow® Solution 100X 

20mL, NovoRinse® Solution 1X 

500mL, NovoClean® Solution 1X 

500mL, NovoCyte® QC Particles 

2mL), NovoSampler® Q, and Oneyear Warranty. 

2010102 ACEA NovoCyte QuanteonTM 

4020 Flow Cytometer and 

NovoSampler® Q Combo 

[ ] 

2010103 ACEA NovoCyte QuanteonTM 

4016 Flow Cytometer and 

NovoSampler® Q Combo 

[ ] 

2010104 ACEA NovoCyte QuanteonTM 

4000C Customer Build Flow 

Cytometer and 

NovoSampler® Q Combo 

[ ]

2020098 ACEA NovoSampler® Q [ ] 

 
PUBLIC SUBMISSION

Detailed product description: 

ACEA NovoCyte QuanteonTM is a Flow Cytometry analyzer instrument that is equipped with 4 lasers 

(violet, blue, yellow, red), and 25 independent silicon photomultipliers (SiPM) detectors for collecting and 

processing signals from each of all 25 fluorescent channels. It was launched globally at May, 2018. 

Its software ACEA NovoExpress® is an easy-to-use and highly intuitive software package for both Flow 

Cytometry data collection and analysis, it provides a powerful range of professional flow cytometry data 

analysis functionalities, as well as turn-key data analysis functions. 

The ACEA NovoSampler® Q is an optional sample handling module to the ACEA NovoCyte Quanteon 

system. The NovoSampler Q is used with the NovoCyte Quanteon Flow Cytometer to achieve automatic 

collection of samples in compatible sample plates or tubes. 

When coupled with this dedicated NovoSampler Q automated sample loader, the ensemble provides 

walk-away operation and automation-ready capabilities for high throughput needs. Furthermore, the 

NovoSampler Q works with a variety of sample formats, including single tubes; multitube racks; or 24-, 

48-, 96-, or 384-well plates. 

The NovoCyte Quanteon is the one and only in the market in that it employs a series of solid-state, 

photon-level-sensitive detectors called silicon photomultipliers (SiPM), which have superb detection 

sensitivity and resolution, which is ideal for dim signal and rare cell population. 

Additionally, the NovoCyte Quanteon has the best side scattering resolution in the market which pushes 

the small particle detection limit down to the 100nm range. 

Furthermore, its flexible configurations allow customer to customize and choose among many 

configurations from 16 detectors to 25 detectors with different ensembles of optical filters. 

As the next generation of the novel and simple-to-use Acea NovoCyte Flow Cytometer (launched globally 

at 2014), the NovoCyte Quanteon will continue to demystify Flow Cytometry and broaden its applications 

in curing cancer, understanding the microbiome, and safeguarding human health, etc. with its simplified, 

automated, and integrated Flow Cytometry solutions. 

Currently, there is no other Flow Cytometry instrument in the same category like Quanteon. Its unique 

and powerful performance is irreplaceable by any other instrument globally. 

Flow Cytometry & Flow Cytometer Background information: Flow cytometry is a technique used by 

both research and clinical users to detect and measure physical and chemical characteristics of a 

population of cells or particles. Flow cytometer is a Flow cytometry instrument, it has two kinds: analyzer 

and sorter. Flow cytometer is generally a term loosely used for Flow cytometry analyzer. 

A sample containing cells or particles are suspended in a sample fluid, the sample is sucked into fluidic 

system of Flow Cytometer through differential pressure, then hydrodynamically focused by sheath fluid 

and injected into the flow cell. Ideally one cell at a time flows through the flow cell and then excited by 

laser beam(s) and the emitted scattered and/or fluorescent light from are characteristic to the cell and 

components of it (e.g. its proteins/nucleic acids labeled by fluorescent dyes or its proteins/nucleic acids 

bound to biomarkers labeled with fluorescent dyes). Tens of thousands of cells can be quickly examined 

and the data gathered are processed by a dedicated Flow Cytometry software program in a computer 
PUBLIC SUBMISSION

workstation. The laser, optics and electronics hardware are managed and commanded by Flow 

Cytometer instrument software and firmware interfaces. The instrument was run, and sample data was 

collected, processed and displayed by its Flow Cytometer software. 

Rationale for Excluding Flow Cytometers from the Section 301 Tariffs 

 The NovoCyte Quanteon flow cytometer instrument provides high performance flow cytometry 

in a benchtop footprint, and is designed to be used by researchers (RUO only) who have varying levels of 

experience with flow cytometry, from novice to experienced users. Additionally, it has a number of novel 

design features that provide higher sensitivity and higher resolution than other flow cytometer 

instruments. 

The ACEA Biosciences NovoCyte Quanteon flow cytometer with NovoSampler Q® is the only flow 

cytometer with automation capabilities at an affordable price range that meets customers’ needs with 

the following features: 

o Have 18~27 detection channels to maximize signal detection and provide flexible configuration 

options: Forward scatter (FSC), side scatter (SSC) and 16~25 fluorescent detection channels 

o Have 16~25 independent silicon photomultipliers (SiPM) detectors for collecting and processing 

signals from each of all 16~25 fluorescent channels 

o Designed to provide users the ability to upgrade the system by adding extra fluorescence channels 

from 16 up to 25, or even tailoring the fluorescence channel specifically according to your needs, 

at a later date after purchase. This ensures that the NovoCyteQuanteon will meet customer’s 

expanding research needs 

o Have four excitation lasers (405nm, 488nm, 640nm, 561nm) at 100mW output power to maximize 

fluorophore options and detections sensitivity 

o Able to detect and resolve particles of size down to 100nm with FSC and SSC 

o Have fluorescence threshold sensitivities of FITC <50 MESFs, APC <15 MESFs, Pacific Blue <30 

MESFs, PE <20 MESFs to enable detection of weak signals or rare populations 

o Have a Fluorescent linearity: R squared >0.99 

o Have spatially separated beams with 10x60uM small beam spot to minimize emission signal 

overlap 

o Employ user-exchangeable filters with embedded “smart” sense to prevent errors 

o Have fixed optics, requiring no operator alignment 

o Have a 7.2 log dynamic range, eliminating the need to set detector voltages and simplifying 

instrument setup 

o Have a large, 170 x 290μm rectangular quartz flow cell to minimize the chance of clogs 

o Have a sample acquisition rate of 50,000 events/seconds to enable rapid data acquisition and thus 

efficient sample processing 

o Have a robust, modular and automated means of sample acquisition and processing that enables: 

 Use of the following versatile sample input formats 

x stationary single tube holder with 12x75mm falcon tube 

x stationary single e-tube holder with 1.5mL or 2mL Eppendorf tube 

x Automated NovoSampler Q with 

o 12x75mm tube (with ACEA 40 tube rack) 
PUBLIC SUBMISSION

o 1.5- and 2.0- mL Eppendorf tubes (workable with ACEA 40 tube 

rack) 

o Standard 96-well plates (V-bottom) 

o Standard 96-well plates (U-bottom) 

o Standard 96-well plates (flat-bottom) 

o Standard 48-well plates 

o Standard 24-well plates 

o Standard 384-well plates 

o Sample agitation by platform-based vertexing 

o 96 plate throughput < 20 minutes 

o 384 plate throughput < 80 minutes 

o Have low carryover at < 0.1% volume 

o Have absolute cell count capability and counting performance of <5% CV 

o Employ a retractable probe and a built-in probe decontamination fluidics system to eliminate the 

possibility of cross-contamination between samples during acquisition 

o Employ NovoExpress, a fully-featured, robust software package enabling: 

 Operation, maintenance and troubleshooting of the flow cytometer 

 Both data acquisition and analysis that is fully integrated into the flow cytometry 

system and offers all the tools needed to collect and analyze data 

 Data export in FCS 3.0, FCS 3.1, and CSV formats for third-party software analysis 

 Drag-and-drop software templating function allows for rapid application of 

settings and analysis across multiple samples 

 Automatic compensation and a quick compensation function allow for the rapid 

generation of compensation matrices. 

 The ability to acquire and analyze data simultaneously in conjunction with the 

NovoSampler Q’s operation 

 Cell Proliferation Analysis module to expand the data analysis capability to model 

the proliferation assay data 

 Built-in cell cycle analysis function (Watson pragmatic model and Dean-Jett-Fox 

model) for enhanced data analysis capability and to eliminate the need for thirdparty software 

 Heat Map function to enable the convenient visualization of the statistical results 

for multiple parameters from multiple samples 

 Bi-variate Plot function to provide a powerful tool to visualize an array of 

fluorescence data plotted against each other and the impact of fluorescence 

compensation on the results 

 Support data exporting to LIS file compatible with the Laboratory Information 

System (LIS) 

 Technical Controls implemented for requirements related to 21 CFR part 11 

compliance, related to Electronic Signatures and Electronic Records. 

o Employ negative-pressure sample acquisition to minimize ambient room noise 

o Have an operating temperature range of 15 to 30 degrees centigrade, enabling optimal 

performance while lessening the strain on the building’s HVAC system 

o Employ simple, automated, fast, one-button procedures for: 

 Startup 

 Cleaning 

 Decontamination 
PUBLIC SUBMISSION

 Shutdown 

o Have instrumentation and consumables that are manufactured in an ISO 9001 environment. 

Its product features and benefits are irreplaceable by other Flow Cytometry products in market. 

Detailed product specifications are shown in Appendix item 1 and 2. 

Optional: customer views (1st one is US customer): 

1. NovoCyte Flow Cytometer at SelectScience - 4.9 out of 5 stars from total 29 reviews 

"I have only wonderful things to say about the Novocyte. It is incredibly easy to use, we get 

reproducible results, the software is the best one out there, the maintenance is super easy, and 

ACEA has excellent technical support! Can't wait to upgrade to the 25-channel instrument!" 

 - By Luz M. Londoño (18 Jul 2018) 

2. Email review: Cytometry@lists.purdue.edu from Purdue Flow list 

“My overall impression is that the Quanteon is a "next-generation NovoCyte" that has managed to 

upgrade an already pretty solid instrument without ruining all the things that made (and still 

make) the NovoCyte a pleasure to work with. 

The Quanteon runs on the same NovoExpress software as the NovoCyte - which definitely 

contributed to our decision to pick this instrument. We currently rely on three ACEA NovoCytes for 

all our routine clinical flowcytometry analyses, and I can vouch for the quality of the 

service/support from this company.” 

 - By Dr. Mikkel Steen Petersen (3 Sept. 2018) 

 





PUBLIC SUBMISSION

 10070537_1 
PUBLIC SUBMISSION

EXHIBIT B 

“NovoCyte” 

Flow Cytometry System 
PUBLIC SUBMISSION

Since 2014, over hundreds of Acea NovoCyte branded flow cytometer instruments have been adopted 

by U.S.-based pharmaceutical companies, academic institutions, and government agencies as a powerful 

tool for broad and in-depth cell research applications in curing cancer, understanding the microbiome, 

and safeguarding human health, etc. 

As a part of NovoCyte® branded flow cytometer product family provided by ACEA Biosciences Inc., ACEA 

NovoCyte® is a flow cytometer instrument capable of detecting up to 15 colors with impressive 

sensitivity and resolution. Within the same instrument box, its customizable lasers (1~3 lasers from Blue, 

Violet, Red, Yellow lasers) and optical configurations (optical filters) offer high degree of flexibility and 

customization to each individual customer’s needs for advanced cell or particle analysis. It enables 

highly sensitive single cell level, multiparametric analysis of millions of cells for a comprehensive view 

towards hidden yet physiologically relevant cellular and molecular events in life sciences. 

The NovoCyte instrument is made from metal shell with electronic integrated circuits, fluidic tubing, low 

power lasers (40~60mW) with optical lenses, etc. It is composed of the optical system, the fluidic 

system, and the electronic system. 

The complete system includes several components below: 

a) flow cytometer instrument with miscellaneous accessories 

b) fluidics station with NovoFlow®, NovoRinse® and NovoClean® and waste fluidic bottles, 

c) the complimentary NovoCyte flow cytometer starter kit includes solutions: NovoFlow® 100X 20mL, NovoRinse® 

1X 500mL, NovoClean® 1X 500mL, NovoCyte® QC Particles 2mL, 

d) controlling computer NovoCyte workstation with NovoExpress® software pre-installed, 

e) automated sampler loader NovoSampler® Pro as an optional autosampler accessory to the instrument. 

The size of flow cytometer instrument itself is ~ 23.6 x 17.7 x 15.4 in (60 x 45 x 39 cm) with weight 

around 86 lbs (39 kg). A minimum space of 150 cm (W) × 80 cm (D) × 90 cm (H) is required to install the 

complete NovoCyte instrument and fluidics station. 

 

In United States, the NovoCyte flow cytometer is for Research Use only, not for use in diagnostic 

procedures. 
PUBLIC SUBMISSION

Related ACEA Biosciences Product Catalog Number, Model Name, Listing Price, Components

ACEA 

Biosciences 

NovoCyte 

Product 

Catalogs 

2010001 

ACEA NovoCyte® 1000 3FL 

Channels 3 PMTs (530/572/675 

nm) [ ] 

Includes Flow Cytometer 

System, Software (total 3 user 

licenses), Workstation, Reagent 

Bottles/Containers, 

Complimentary NovoCyte Flow 

Cytometer Starter Kit 

(NovoFlow® Solution 100X 

20mL, NovoRinse® Solution 1X 

500mL, NovoClean® Solution 1X 

500mL, NovoCyte® QC Particles 

2mL), and One-year Warranty. 

2010034 

ACEA NovoCyte® 1040 4FL 

Channels 4PMTs 

(530/572/675/780 nm) [ ] 

2010035 

ACEA NovoCyte® 1050 5 FL 

Channels 5PMTs 

(530/572/615/675/780 nm) [ ] 

2010002

ACEA NovoCyte® 2000R 4FL 

Channels 3 PMTs (530/572/675 

nm) [ ]

2010004 

ACEA NovoCyte® 2060R 6FL 

Channels 4 PMTs 

(530/572/675/780 nm) [ ] 

2010065 

ACEA NovoCyte® 2070R 7FL 

Channels 5 PMTs 

(530/572/615/660/780 nm) [ ] 

2010025 

ACEA NovoCyte® 2070V 7FL 

Channels 4PMTs 

(445/530/572/695 nm) [ ] 

2010067

ACEA NovoCyte® 2090V 9FL 

Channels 5 PMTs 

(445/530/572/695/780 nm) [ ]

2010027 

ACEA NovoCyte® 2110V 11 FL 

Channels 6 PMTs 

(445/530/572/660/695/780 nm) [ ] 

2010011 

ACEA NovoCyte® 3000 13FL 

Channels 6 

PMTs (445/530/572/615/675/780 

nm) [ ] 

2010064 

ACEA NovoCyte® 3005 14-15 FL 

Channels 6 PMTs 

(445/530/572/660/725/780 nm) [ ] 

2010041 

ACEA NovoCyte® 3000RYB 13FL 

Channels 6 PMTs 

(530/586/615/660/695/780 nm) [ ] 

2010042 

ACEA NovoCyte® 3000VYB 13FL 

Channels 6 PMTs 

(445/530/586/615/660/780 nm) [ ] 

2010066 

ACEA NovoCyte® 1000Y 5FL 

Channels 5 PMTs 

(586/615/660/695/780 nm) [ ] 
PUBLIC SUBMISSION

2010043 

ACEA NovoCyte® 2100Y 10FL 

Channels 6 PMTs 

(530/586/615/660/695/780 nm) [ ] 

2010047 

ACEA NovoCyte® 1000 and 

NovoSampler Pro Combo [ ] 

Includes Flow Cytometer 

System, Software (total 3 user 

licenses), Workstation, Reagent 

Bottles/Containers, 

Complimentary NovoCyte Flow 

Cytometer Starter Kit 

(NovoFlow® Solution 100X 

20mL, NovoRinse® Solution 1X 

500mL, NovoClean® Solution 1X 

500mL, NovoCyte® QC Particles 

2mL), NovoSampler® Q, and 

One-year Warranty. 

2010079 

ACEA NovoCyte® 1040 and 

NovoSampler Pro Combo [ ] 

2010080 

ACEA NovoCyte® 1050 and 

NovoSampler Pro Combo [ ] 

2010048 

ACEA NovoCyte® 2000 and 

NovoSampler® Pro Combo [ ] 

2010049 

ACEA NovoCyte® 2060 and 

NovoSampler® Pro Combo [ ] 

2010071 

ACEA NovoCyte® 2070R and 

NovoSampler® Pro Combo [ ] 

2010077

ACEA NovoCyte® 2070V and 

NovoSampler® Pro Combo [ ] 

2010073 

ACEA NovoCyte® 2090V and 

NovoSampler® Pro Combo [ ] 

2010081

ACEA NovoCyte® 2110V and 

NovoSampler® Pro Combo [ ] 

2010050 

ACEA NovoCyte® 3000 and 

NovoSampler® Pro Combo [ ] 

2010070

ACEA NovoCyte® 3005 and 

NovoSampler® Pro Combo [ ] 

2010044 ACEA NovoCyte® 3000RYB and 

NovoSampler® Pro Combo [ ] 

2010045 ACEA NovoCyte® 3000VYB and 

NovoSampler® Pro Combo [ ] 

2010072 

ACEA NovoCyte® 1000Y and 

NovoSampler® Pro Combo [ ] 

2010046 

ACEA NovoCyte® 2100YB and 

NovoSampler® Pro Combo [ ] 

2020070 ACEA NovoSampler® Pro [ ] 

2020083 NovoCyte SIP Upgrade Kit [ ] 

2020039 

System Upgrade from NovoCyte® 

1000 to 2000 4FL Channels 

(530/572/675 nm) 

[ ] 

2020040 

System Upgrade from NovoCyte® 

1000 to 2060R 6 FL Channels 

(530/572/675/780 nm) 

[ ] 

2020041 

System Upgrade from NovoCyte® 

2000 to 2060R 6 FL Channels 

(530/572/675/780 nm) 

[ ] 
PUBLIC SUBMISSION

2020087 

System Upgrade from NovoCyte® 

2000 to 3000 13 FL Channels 

(445/530/572/615/675/780 nm) 

[ ] 

2020042 

System Upgrade from NovoCyte® 

2060R to 3000 13 FL Channels 

(445/530/572/615/675/780 nm) 

[ ] 

2020043 

System Upgrade from NovoCyte® 

1000 to 3000 13 FL Channels 

(445/530/572/615/675/780 nm) 

[ ] 

2020053 

System Upgrade from NovoCyte® 

1000 to 2070V 7 FL Channels 

(445/530/572/675 nm) 

[ ] 

2020054 

System Upgrade from NovoCyte® 

1000 to 2110V 11 FL Channels 

(445/530/572/615/675/780 nm) 

[ ] 

2020074 

System Upgrade from NovoCyte® 

1000 to 2100YB 10 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020075 

System Upgrade from NovoCyte® 

2000 to 3000RYB 13 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020076 

System Upgrade from NovoCyte® 

2060 to 3000RYB 13 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020077 

System Upgrade from NovoCyte® 

2100YB to 3000VYB 13 FL 

Channels 

(445/530/586/615/660/780 nm) 

[ ] 

2020054 

System Upgrade from NovoCyte® 

1000 to 2110V 11 FL Channels 

(445/530/572/615/675/780 nm) 

[ ] 

2020074 

System Upgrade from NovoCyte® 

1000 to 2100YB 10 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020075 

System Upgrade from NovoCyte® 

2000 to 3000RYB 13 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020076 

System Upgrade from NovoCyte® 

2060 to 3000RYB 13 FL Channels 

(530/586/615/660/695/780 nm) 

[ ] 

2020077 

System Upgrade from NovoCyte® 

2100YB to 3000VYB 13 FL 

Channels 

(445/530/586/615/660/780 nm) 

[ ] 
PUBLIC SUBMISSION

Detailed product description: 

ACEA NovoCyte is a Flow Cytometry analyzer instrument that can be equipped with 1~3 lasers (violet, 

blue, yellow, red), capable of detecting up to 15 fluorescent channels/colors using 6 shared PMT 

detectors with impressive sensitivity and resolution. It was launched at 2014. 

Its software ACEA NovoExpress® is an easy-to-use and highly intuitive software package for both Flow 

Cytometry data collection and analysis, it provides a powerful range of professional flow cytometry data 

analysis functionalities, as well as turn-key data analysis functions. 

The ACEA NovoSampler® Pro is an optional sample handling module to the ACEA NovoCyte system. The 

NovoSampler Pro is used with the NovoCyte Flow Cytometer to achieve automatic collection of samples 

in compatible sample plates or tubes. 

When coupled with this dedicated NovoSampler Pro automated sample loader, the ensemble provides 

walk-away operation and automation-ready capabilities for high throughput needs. Furthermore, the 

NovoSampler Pro works with a variety of sample formats, including single tubes; or 24-, 48-, 96-well 

plates. 

Furthermore, its flexible configurations allow customer to customize and choose among many 

configurations from 3 to 15 fluorescent channels with different ensembles of optical filters. 

Ever since the global launch of this novel and simple-to-use Acea NovoCyte Flow Cytometer, over 1000 

instruments have been placed worldwide, NovoCyte Flow Cytometer has been cited in over 500 peerreviewed publications. It has demystified Flow Cytometry and broadened its applications in curing 

cancer, understanding the microbiome, and safeguarding human health, etc. with its simplified, 

automated, and integrated Flow Cytometry solutions. 

Currently, there is no other Flow Cytometry instrument in the same category like NovoCyte. Its unique 

and powerful performance is irreplaceable by any other instrument globally. 

Flow Cytometry & Flow Cytometer Background information: Flow cytometry is a technique used by 

both research and clinical users to detect and measure physical and chemical characteristics of a 

population of cells or particles. Flow cytometer is a Flow cytometry instrument, it has two kinds: 

analyzer and sorter. Flow cytometer is generally a term loosely used for Flow cytometry analyzer. 

A sample containing cells or particles are suspended in a sample fluid, the sample is sucked into fluidic 

system of Flow Cytometer through differential pressure, then hydrodynamically focused by sheath fluid 

and injected into the flow cell. Ideally one cell at a time flows through the flow cell and then excited by 

laser beam(s) and the emitted scattered and/or fluorescent light from are characteristic to the cell and 

components of it (e.g. its proteins/nucleic acids labeled by fluorescent dyes or its proteins/nucleic acids 

bound to biomarkers labeled with fluorescent dyes). Tens of thousands of cells can be quickly examined 

and the data gathered are processed by a dedicated Flow Cytometry software program in a computer 

workstation. The laser, optics and electronics hardware are managed and commanded by Flow 

Cytometer instrument software and firmware interfaces. The instrument was run, and sample data was 

collected, processed and displayed by its Flow Cytometer software. 
PUBLIC SUBMISSION

Rationale for Excluding Flow Cytometers from the Section 301 Tariffs 

 The NovoCyte flow cytometer instrument provides high performance flow cytometry in a 

benchtop footprint, and is designed to be used by researchers (RUO only in US) who have varying levels 

of experience with flow cytometry, from novice to experienced users. Additionally, it has a number of 

novel design features that provide higher sensitivity and higher resolution than other flow cytometer 

instruments. 

The ACEA Biosciences NovoCyte flow cytometer with NovoSampler Pro® is the only flow 

cytometer with automation capabilities at an affordable price range that meets customers’ needs with 

the following features: 

x Have up to three excitation laser options (from 4 laser options: 405nm, 488nm, 640nm, 561nm) 

to maximize fluorophore options 

x Have unique laser beam adjustment – independent lenses are used for each laser line so 

independent adjustments can be made 

x Have fixed optics, requiring no operator alignment 

x Have up to 17 detection channels to maximize signal detection: Forward scatter (FSC), side 

scatter (SSC) and up to 15 fluorescent detection channels 

x Have shared PMTs – allow for better efficiency, cost benefit without sacrificing performance 

x Must employ user-exchangeable filters 

x Have a 24-bit 7.2 log dynamic range, eliminating the need to set photomultiplier (PMT) voltages 

and simplifying instrument set up 

x Have a spatial arrangement of its high-quality lasers (spatially separated beams to minimize 

emission signal overlap) and optical system, electronic signal processing and the obscuration bar 

design together result in high sensitivity and resolution for both scattered light signals and 

fluorescence signals 

o Have a fluorescence threshold sensitivity of < 75 MESF for FITC and < 50 MESF for PE; 

<20 MESF for APC to enable detection of weak signals. 

o Light scatter detection angles at FSC: 0+/-13 degrees; SSC: 0+/-46 degrees 

o Fluorescent linearity: R squared >0.99 for 6 bead MESF vs. MFI plot 

x Have a large, 170 x 290μm quartz flow cell to minimize the chance of clogs 

x Have low carryover at < 0.1% volume 

x Have absolute cell count capability and counting performance of <5% CV 

x Have a sample acquisition rate of 35,000 events/seconds to enable rapid data acquisition and 

thus efficient sample processing 

x NovoSampler Pro enables a robust, modular and automated walk-away means of sample 

acquisition and processing that enables Use of the following sample input formats 

o 24 tubes measuring 12x75mm 

o 1.5mL and 2.0mL tubes 

o 24-well (standard) microwell plates 

o 48-well microwell plates 

o 96-well (flat-bottom, U-bottom, V-bottom) microwell plates 

x NovoSampler Pro allows to begin running multiple samples in plates or racks and walk away 

until it is finished, can incorporate automatic shutdown after samples are finished as well 
PUBLIC SUBMISSION

x NovoSampler Pro has ability to easily add it onto the instrument or take it off and use individual 

tubes (<5min). Allow for added flexibility since it does not have to be permanently attached. 

Have sample agitation by platform-based vertexing 

x Employ a retractable probe and a built-in probe decontamination fluidics system to eliminate 

the possibility of cross-contamination between samples during acquisition 

x Have flow rates that are customizable from 5-120 μL/min with corresponding core diameters of 

4.6-22.7 μm. 

x ,ĂǀĞĂƐĂŵƉůĞĂƐƉŝƌĂƚŝŽŶǀŽůƵŵĞŽĨϭϬʅ>- 5mL. 

x Employ NovoExpress, a fully-featured, robust software package enabling: 

o Operation, maintenance and troubleshooting of the flow cytometer 

o Both data acquisition and analysis that is fully integrated into the flow cytometry system 

and offers all the tools needed to collect and analyze data 

o Data export in FCS 3.0, FCS 3.1, and CSV formats for third-party software analysis 

o Drag-and-drop software templating function allows for rapid application of settings and 

analysis across multiple samples 

o Automatic compensation and a quick compensation function allow for the rapid 

generation of compensation matrices. 

o The ability to acquire and analyze data simultaneously in conjunction with the 

NovoSampler Pro’s operation 

o Cell Proliferation Analysis module to expand the data analysis capability to model the 

proliferation assay data 

o Built-in cell cycle analysis function (Watson pragmatic model and Dean-Jett-Fox model) 

for enhanced data analysis capability and to eliminate the need for third-party software 

o Heat Map function to enable the convenient visualization of the statistical results for 

multiple parameters from multiple samples 

o Bi-variate Plot function to provide a powerful tool to visualize an array of fluorescence 

data plotted against each other and the impact of fluorescence compensation on the 

results 

o Support data exporting to LIS file compatible with the Laboratory Information System (LIS) 

o Technical Controls implemented for requirements related to 21 CFR part 11 compliance, 

related to Electronic Signatures and Electronic Records. 

x Employ negative-pressure sample acquisition to minimize ambient room noise 

x Have an operating temperature range of 15 to 32 degrees centigrade, enabling optimal 

performance while lessening the strain on the building’s HVAC system 

x Employ simple, automated, fast, one-button procedures for: 

o Startup 

o Cleaning 

o Decontamination 

o Shutdown 

x Designed to provide users the ability to upgrade the system by adding lasers and extra 

fluorescence channels, or even tailoring the fluorescence channel specifically according to 

customer’s needs, at a later date after purchase. This ensures that the NovoCyte will meet 

customer’s expanding research needs for years to come. 

x Have highly accurate pressure sensors in the fluidic pathway to monitor the system status in real 

time. Abnormal flow is reported on the NovoExpress software and may be resolved by one-click 

execution of automated procedures to backflush, debubble, unclog, prime, rinse, or clean the 

system. 
PUBLIC SUBMISSION

x Have SIP movement with negative pressure sample collection – lowers the risk of aerosol 

production which is important when working with hazardous materials 

x Have ability to analyze data and collect data simultaneously 

x Have automatic clog detection and recovery – the ability to automatic detect a clog in the 

system and perform the necessary steps to clear the clog. This is important for researchers to 

minimize down time by reducing service calls on the instrument. 

x Have instrumentation and consumables that are manufactured in an ISO 9001 environment. 

Its product features and benefits are irreplaceable by other Flow Cytometry products in market. 

Detailed product specifications are shown in Appendix item 1. 

Optional: customer reviews: 

NovoCyte Flow Cytometer at SelectScience - 4.9 out of 5 stars from total 29 reviews 

"I have only wonderful things to say about the Novocyte. It is incredibly easy to use, we get 

reproducible results, the software is the best one out there, the maintenance is super easy, and 

ACEA has excellent technical support! Can't wait to upgrade to the 25-channel instrument!" 

 - By Luz M. Londoño (18 July 2018) 

”My best friend in the lab!!!” 

“This (NovoExpress) software is straightforward, and the software interface is easy to handle. The 

implemented auto compensation and hierarchic tree structure is a highlight for effective 

organization of experimental data.” 

– Joan Christiansen, H. Lundbeck A/S. (July, 2018) 

 
PUBLIC SUBMISSION

Appendix: 

Item 1: NovoCyte Flow Cytometer Technical Specifications 

 10070544_1