3500xL Dx Genetic Analyzer for Sequencing

The 3500 Dx System Series is our first CE- IVD marked capillary electrophoresis instrument, designed to comply with the Directive 98⁄79⁄EC on In Vitro Diagnostic Medical Devices. The IVD mark declares conformity of the 3500 Dx Series with this directive, which provides additional security and confidence to laboratories.

• 8 capillary 3500 Dx system that can be upgraded easily to the 24 capillary 3500xL Dx System
• New single-line 505 nm, solid-state long-life laser utilizes a standard power supply; requires no heat-removal ducting
• Powerful, integrated data collection and primary analysis software provides real-time assessment of data quality
• Radio Frequency Identification (RFID) technology tracks key consumables data and records administrative information
• Simple setup, operation and maintenance – the easiest-to-run, easiest-to-own DNA sequencer to date

Fast, Reliable Data
The 3500 Dx Series includes a 50 cm array with POP™-7 polymer configuration with fast run times approximately equivalent to 36 cm array modules on previous generations of capillary electrophoresis platforms. New short-read sequencing modules enable sequence collection of up to 300 bp in 30 minutes to improve throughput where data needs to be obtained quickly with the desired confidence in base calling reliability.

Complete Solution
The 3500 Dx Series includes the CE and IVD-marked instrument, as well as CE and IVD-marked consumables, reagents, and data collection software, bringing together a comprehensive system designed to support the demanding needs of process-controlled environments, while delivering the unsurpassed data quality scientists and clinicians expect from us. The Applied Biosystems 3500 Dx Genetic Analyzer has the following components:
• CE-IVD Marked Capillary electrophoresis Instrument
• CE-IVD Marked 8-capillary 3500 Dx series array and 3500 Dx series POP7 Polymer
• CE-IVD Marked 3500 Dx series BigDye™ Terminator v3.1 Sequencing Standard Kit
• IVD Marked 3500 Dx series Data Collection Software to perform data collection, primary analysis, quality control and instrument control and maintenance tasks

Note: Also included is a Dell computer workstation with a flat screen monitor. The Service Sequencing Chemistry Installation Kits for system installation IVD-Labeled Accessories also available are:
• 96-well retainer and base, Standard and Fast Set
• 8 tubes and retainer, Standard and Fast Set
• Septa-8-strip tubes, Septa-96-well plate, Septa-384-well plate
• Septa for Cathode Buffer Container

Ready to Use Consumables With RFID Tags
The 3500 Dx series introduces ready-to-use consumables with pre-packaged polymer pouches, cathode and anode buffer containers and easy-to-install capillary arrays. Each of these consumables is integrated with RFID tags that enable viewing, tracking and reporting of critical information about reagents and consumables including usage, lot number, part number, expiry date and on-instrument lifetime within the 3500 Dx Series Data Collection Software.

Easy to Use New Data Collection Software
3500 Dx Series Data Collection software breaks new ground in user-friendly navigation with an intuitive dashboard design, highly visible buttons for common operations, easy-to-read graphical displays to monitor the state of consumables and handy maintenance scheduling calendar functionality. New functionality includes simplified plate set-up, built-in primary analysis with quality control, so you can make decisions about the quality of data as it is produced on the instrument without the need to transfer output files into secondary analysis software packages.

Note:
The IVD use is demonstrated by generating sequencing information from the primary control material, the BigDye™ Terminator v3.1 Sequencing Standard Kit. Use of sequencing and fragment analysis applications on the 3500 Dx system are classified as Non-Diagnostic use and will require self-validation by appropriate laboratory personnel developing or running such applications.

The 3500 Dx Series are intended for use by trained operators in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility. Users are responsible for any validation of assays and compliance with any regulatory requirements that pertain to their procedures and instrument use.