Applied Biosystems 3500xL Dx Genetic Analyzer

The Applied Biosystems 3500xL Dx Genetic Analyzer is the first capillary electrophoresis platform for in vitro diagnostic (IVD) use for Sanger sequencing and fragment analysis of DNA. Sanger sequencing and fragment analysis are known as the 'gold-standard' for its accuracy, reliability, and ease of use.

Confidence in your results
You can now feel even more comfortable adopting the 3500xL Dx Genetic Analyzer platform for IVD use for Sanger sequencing and fragment analysis of DNA.
• The 3500xL Dx Genetic Analyzer is an IVD-labeled platform for Sequencing-Based Typing using SeCore HLA typing kits
• High accuracy: 99% concordance as shown in clinical trials using SeCore HLA typing kits
• The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer are FDA-cleared for DNA fragment analysis with the AmplideX™ Fragile X Dx and Carrier Screen Kit from Asuragen, Inc.
• Direct injection of PCR products (no PCR clean up) into the Applied Biosystems 3500xL Dx Genetic Analyzer

Simplicity and efficiency
The 3500xL Dx Genetic Analyzer is a partner in your laboratory, making it easy for you to comply with various industry standards and simplifying the training of new users.
• Minimal 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, audit, and electronic signature (SAE), radio frequency identification (RFID) tracking of consumables, built-in quality controls, and real-time data quality evaluation

Flexibility
• Collect data in IVD mode which is validated for sequencing using the SeCore HLA kit and validated for fragment analysis
• Different configurations to meet your throughput needs: 8-capillary (3500 Dx Genetic Analyzer) and 24-capillary (3500xL Dx Genetic Analyzer) versions
• Integrated, dual-mode software for instrument control, data collection, quality control, and auto-analysis of sample files

IVD-labeled accessories and consumables
The purchase of a 3500xL Dx Genetic Analyzer includes a computer system and associated data collection software, as well as an installation kit containing the initial set of accessories and reagents. Installation includes a full install qualification and operational qualification, as well as instrument training.

The 3500 Dx Genetic Analyzer is backed by a comprehensive service and support program with options to purchase additional services depending upon your laboratory maintenance and audit requirements.

Intended use—Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis.

The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.

Intended Use—AmplideX Fragile X Dx & Carrier Screen Kit
The AmplideX Fragile X Dx & Carrier Screen Kit is an in vitro diagnostic device that uses polymerase chain reaction (PCR) and capillary electrophoresis to detect and identify the number of cytosine-guanine-guanine (CGG) repeats in the fragile X mental retardation-1 (FMR1) gene using genomic DNA isolated from peripheral whole blood specimens. It is solely intended as an aid in the post-natal diagnosis of fragile X syndrome, and fragile X-associated disorders [i.e., fragile X-associated tremor/ataxia syndrome (FXTAS) or fragile X-associated primary ovarian insufficiency (FXPOI)], and for carrier testing in adults of reproductive age. Assay results are solely intended to be interpreted by healthcare professionals who are board certified in molecular genetics and to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice. Reflex testing, clinical genetic evaluation, and genetic counseling should be offered as appropriate. The test is for use on the Applied Biosystems 3500 Dx Series Genetic Analyzers.

This test is not indicated for use for fetal diagnostic testing, newborn screening, or for stand‐alone diagnostic purposes.

Note: The 3500xL Dx Genetic Analyzer data collection software uses the Windows 10 operating system.