With breakthrough hardware design, a new approach to consumables, and powerful enabling software, the 3500 Dx Genetic Analyzers CS2 systems help deliver new levels of performance and convenience to the work that you do every day. The 3500 Dx Genetic Analyzers CS2 embody the commitment by Life Technologies to providing laboratories with the most trusted, versatile, and innovative tools for molecular diagnostic testing.

Overview of the 3500 Dx Genetic Analyzer CS2

It's accurate
Based on one of the most widely used, widely trusted sequencing methodologies available—Sanger sequencing—the 3500 Dx Genetic Analyzer CS2 is designed to deliver the accuracy you demand.

It works the way you do
Designed with you in mind, the 3500 Dx Genetic Analyzer CS2 gives you automated operation, easy-to-install consumables, electronic tracking of instrument performance and maintenance tasks, and integrated analysis software—so you can focus on the outcome.

It's flexible
You can run the instrument in either IVD mode (for diagnostic HLA typing by SeCore® HLA typing kits) or RUO mode to develop other applications, including de novo sequencing and resequencing, as well microsatellite analysis, MLPA®, LOH, MLST, and SNP confirmation or screening and fragment analysis.

It's backed by award-winning support
Keeping your lab operational is critical. Our technical and field service support staff respond quickly to your calls, so that you can continue to respond to those who depend on you for results.

Product Information

3500 Dx CS2

The 3500 Dx Genetic Analyzers CS2 systems include the in vitro diagnostic (IVD)–labeled instrument, data collection software, and IVD consumables and reagents—the tools you need for high-quality results in your process-controlled environment. The systems have been validated using SeCore® HLA kits and uTYPE® Dx software for powerful, rapid data analysis and high accuracy in HLA typing. In addition to the diagnostic SeCore® HLA assay that you can run in IVD mode, the 3500 Dx Genetic Analyzers CS2 systems allow you to develop new assays in RUO mode. The 3500 Dx Genetic Analyzers CS2 are available in two throughput options—3500 Dx (8-capillary) low throughput and 3500xL Dx (24-capillary) medium throughput.

Confidence in results

  • Helps regulated laboratories maintain compliance
  • Provides high accuracy—confirmed with external clinical studies at >99% concordance
  • Minimizes human error

Simplicity and efficiency

  • Helps to streamline laboratory processes
  • Delivers results in as fast as 60 min (instrument run-time)
  • Reduces instrument hands-on time with simplified installation and removal of consumables and accessories

Flexibility

  • Supports research applications and assay development
  • Offers development options in RUO mode such as de novo sequencing and resequencing as well as fragment analysis (microsatellite analysis, MLPA®, LOH, MLST, SNP confirmation or screening)

Features & Benefits

Putting you in the driver's seat

3500 Dx CS2

3500 Dx Data Collection Software is IVD-labeled and breaks new ground in user-friendly navigation, with an intuitive dashboard design including:

  • Easy-to-read graphical displays to monitor the state of consumables
  • Handy maintenance scheduling calendar
  • New architecture simplifies plate setup, data collection, and analysis workflow

Snap in and run

  • Primary consumables are IVD-labeled and contain novel, integrated Radio Frequency Identification (RFID)-tagged labels that enable viewing, tracking, and reporting of critical information
  • New preformulated consumable packages make the 3500 Dx the most user-friendly genetic analyzer on the market today
  • Automatic tracking minimizes administrative tasks and reduces the chance of error or omission

Capillary array

  • IVD-labeled capillary array with built-in frame is easy-to-install
  • Internally uncoated capillaries are supplied in assemblies of 8 or 24 capillaries per array
  • Integrated RFID label enables viewing, tracking, and reporting of capillary array information

Learn more ›

Cathode buffer container

  • IVD-labeled, prefilled container with Prefilled container with 1X buffer to support all electrophoresis applications
  • Container has two separate compartments:
    • Left side contains the cathode buffer
    • Right side contains polymer waste from the capillary wash between injections
  • Integrated RFID label enables viewing, tracking, and reporting of critical information

Learn more ›

Anode buffer container

  • IVD-labeled, prefilled container with 1X buffer
  • Maintains a source of ions and correct pH for electrophoresis
  • Integrated RFID label enables viewing, tracking, and reporting of critical information

Learn more ›

Performance Optimized Polymer

  • IVD-labeled POP-6™ Polymer is designed in ready-to-use, load-and-run pouches
  • Integrated RFID label enables viewing, tracking, and reporting of polymer information

Learn more ›

Operates on standard power
The 3500 Dx Series is easy to install and operate:

  • New solid-state 505 nm excitation laser technology and thermal design reduces instrument footprint
  • Plugs directly into standard power
  • No need for excess heat-removal ducting
 

Feature

Benefit

FDA & Health Canada-cleared instrumentAn instrument that is built according to GMP to help meet your lab's compliance requirements
RFIDInstrument automatically checks for the use of correct product and expiration dates
IVD reagents/accessoriesTested and built to operate optimally with the 3500 Dx platform
SAESecurity, audit, and electronic signature capability to help meet compliance to governing regulations
8-capillary or 4-capillary modelsSelect the appropriate instrument to meet your laboratory throughput needs
FlexibilityBoth IVD and RUO modes to allow you to adhere to your lab's development requirements—sequencing or fragment analysis applications

Literature

  • Specification Sheet
  • Get detailed information on the 3500 Dx Genetic Analyzers CS2 features and benefits.

IVD Assays

HLA Typing
The 3500 Dx Genetic Analyzers CS2 (8- and 24-capillary) are FDA and Health Canada-cleared for HLA typing with SeCore® HLA typing kits and uTYPE® Dx HLA Sequence Analysis Software.

SeCore® HLA typing kits provide a complete set of reagents and protocols for high-resolution HLA genotyping on 3500 Dx Genetic Analyzers CS2. uTYPE® Dx HLA Sequence Analysis Software is designed to perform accurate allele identification, including queries to the latest allele library for HLA genotyping.

Frequently Asked Questions

What IVD assays are available?
SeCore® HLA typing kits are validated for use with the 3500 Dx Genetic Analyzers CS2.

What IVD reagents are available for the 3500 Dx instruments?
POP-6™ polymer, BigDye® Terminator v1.1, long-read sequencing standard, anode buffer container, cathode buffer container, and conditioning reagent are all available. The system can also accommodate other reagents in RUO mode.

Can a 3500 RUO instrument be upgraded to a Dx?
No, because of differences in the regulated manufacturing processes for IVD instruments, upgrading from RUO to Dx is not possible. A trade-in program is available and applies to all CE instruments.

What applications does the instrument support?
In IVD mode, the system supports HLA typing using SeCore® kits. The following development options are available in RUO mode: de novo sequencing and resequencing, as well as fragment analysis applications such as microsatellite analysis, MLPA®, LOH, MLST, SNP confirmation or screening.

How large is the instrument?
The instrument's dimensions (W x D x H) are 61 x 61 x 72 cm (24 x 24 x 28 in). It weighs 82 kg (181 lbs). Width with door open is 122 cm (48 in).

How long does it take to run a typical CE assay?
The instrument time for a single run is as fast as 60 min.

Service Plans

Beyond repair to proactive care
The AB® Assurance Plan is our premium repair plan, designed to maximize instrument performance and help ensure availability of critical systems. The AB® Assurance Plan will help keep your laboratory running smoothly with preventive maintenance, proactive instrument monitoring, and—should one of your instruments require repair—fast response. And, for the FDA & Health Canada-cleared instrument 3500 Dx Genetic Analyzers CS2, there is the added benefit of a qualification service or system performance check performed after each repair or planned maintenance event.

Qualification services
In regulated industries, compliance with government and international standards requires documented verification that your systems are installed and functioning according to their manufacturer's intended use. Whether you need Installation Qualification and Operation Qualification (IQ/OQ) or Instrument Performance Qualification (PQ), our qualification services provide audit-quality data to share with your regulated body and verify that your instrument is working according to manufacturer's specifications.

Computer System Validation (CSV)
An instrument qualification service is only the starting point to your validation. Our Compliance Services professionals partner with you and can help you get into production faster, while controlling CSV costs and getting you audit-ready faster.

Service plan options for the 3500 Dx and 3500XL Dx Genetic Analyzers CS2

  AB Assurance with qualification services* AB Assurance with system performance check*
On-site response time for repairs (business days)Guaranteed 2 business daysGuaranteed 2 business days
Remote instrument monitoring and diagnosticsyesyes
Priority phone and email access to instrument supportyesyes
Application technical supportyesyes
Instrument operating software updatesyesyes
Instrument qualification servicesyes 
Instrument system performance check yes
Planned maintenanceyesyes
Parts, labor, and travelyesyes

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