3500 Dx Genetic Analyzer CS2

The 3500 Dx Genetic Analyzer CS2 is the latest addition to our family of Applied Biosystems® genetic analyzers based on capillary electrophoresis. The 3500 Dx Genetic Analyzer CS2 is an IVD-labeled instrument, making it the first Sanger sequencing platform cleared for sequencing analysis of DNA.

Confidence in Your Results
• The 3500 Dx Genetic Analyzer CS2 is an IVD-labeled platform for Sequencing-Based Typing using SeCore® HLA typing kits. Sanger sequencing is known as the 'gold-standard' for its accuracy, reliability, and ease of use. It is also used for confirmatory sequencing by clinical labs.
• High accuracy: 99% concordance as shown in clinical trials using SeCore® HLA typing kits
• Proven through decades of results—including sequencing of the first human genome—Applied Biosystems® genetic analysis systems are trusted standards for Sanger sequencing.

You can now feel even more comfortable adopting the 3500 Dx Genetic Analyzer CS2 platform for the development of assays for FDA submission.

Simplicity and Efficiency
• Reduced instrument hands-on time with simplified installation and removal of consumables and accessories
• Controlled and efficient run setup with intuitive user interface, preconfigured plate templates, and software-controlled functions (plate setup, data collection, analysis)
• Instrument run-times as short as 1 hour; sample-to-result in as little as 1.5 days
• Maintenance calendar with programmable prompts and service history
• Security and electronic signature, RFID (radio frequency identification) tracking of consumables, built-in quality controls, and real-time data quality evaluation

The 3500 Dx Genetic Analyzer CS2 is a partner in your laboratory, making it easy for you to comply with various industry standards and simplifying the training of new users.

Flexibility
• Collect data in either IVD (diagnostic for HLA typing) or RUO mode
• Develop other applications in RUO mode, including de novo sequencing and re-sequencing, as well as fragment analysis applications such as microsatellite analysis, MLPA®, LOH, MLST, and SNP confirmation or screening
• Partner with us to develop assays for FDA submission
• Different configurations to meet your throughput needs: 8-capillary (3500 Dx) and 24-capillary (3500xL Dx) versions

The 3500 Dx Genetic Analyzer CS2 is a trusted capillary electrophoresis-based sequencing platform for development of your new assays. Capillary electrophoresis-based applications are supported by a large number of publications over the many years that these applications have been used successfully in laboratory testing.

IVD-labeled Accessories and Consumables
The purchase of a 3500 Dx Genetic Analyzer CS2 includes a computer system and associated Data Collection software, as well as an installation kit containing the initial set of accessories and reagents needed to start using the instrument right away. The 3500 Dx Genetic Analyzer CS2 installation includes a full install qualification and operational qualification, as well as instrument training to introduce you to your new genetic analyzer.

The 3500 Dx is backed by a comprehensive Service & Support program with options to purchase additional services depending upon your laboratory maintenance and audit requirements.

Intended Use
The Applied Biosystems® 3500 Dx and 3500xL Dx Genetic Analyzers CS2 with 3500 Dx Series Software 2011 (v1) are in vitro diagnostic devices intended for the sequencing (detection and identification) of fluorescently labeled DNA by capillary electrophoresis.

The Applied Biosystems® 3500 Dx/3500xL Dx Genetic Analyzers CS2 with 3500 Dx Series Software 2011 (v1) are indicated for use with FDA-cleared or approved sequencing assays specifying their use and only by technologists trained in laboratory techniques, procedures, and use of the analyzer.

Note: The 3500 Dx Genetic Analyzer CS2 data collection software uses Windows 7 SP0 operating system. This makes the currently available RUO secondary analysis software incompatible for use on the same system. A separate computer is required to do secondary analysis if operating in RUO mode.