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Applied Biosystems 3500 Dx Series Genetic Analyzer (CE-IVD, IVDR)
Accurate. Simple. Flexible.
The 3500-Series Genetic Analyzers are Now IVDR-Compliant
We have recently updated our acclaimed Applied Biosystems 3500 and 3500 xL Dx Genetic analyzers to comply with the IVDR.
Clients previously frustrated that these powerful devices were not available in the European Union can breathe easy knowing that their new IVDR-compliant Applied Biosystems Genetic Analyzer is only an order away.
The Applied Biosystems 3500 Dx Series genetic analyzers with 3500 Dx Series Data Collection Software 3 IVD v3.2 deliver flexibility by offering dual-mode capability within the same system to help meet the needs of today and tomorrow.
The secure Diagnostic Mode supports run modules that will perform both Sanger sequencing and fragment analysis.
To accommodate various demands on throughput, we offer two models*: the 8-capillary 3500 system for low throughput and 24-capillary 3500xL system for medium throughput, giving you even more flexibility to meet your lab's throughput needs.
Developed with the needs of clinical labs in mind
The Applied Biosystems 3500 Dx series genetic analyzers with 3500 Dx Series Data Collection Software 3 IVD v3.0.1 deliver flexibility by offering dual-mode capability within the same system to help meet the needs of today and tomorrow.
The secure Diagnostic Mode supports run modules that will perform both Sanger sequencing and fragment analysis.
To accommodate various demands on throughput, we offer two models*: the 8-capillary 3500 system for low throughput and 24-capillary 3500xL system for medium throughput, giving you even more flexibility to meet your lab's throughput needs.
Featured resources
Fragment analysis now supported in IVD mode
Fragment analysis comprises a series of techniques in which DNA fragments are fluorescently labeled, separated by capillary electrophoresis, and sized by comparison to an internal standard. Analysis of DNA fragments enables a variety of applications.
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Genetic Analyzer are now enabled for both Sanger sequencing and fragment analysis in IVD mode; therefore, assays can be developed for both Sanger sequencing and fragment analysis on the same system. If you already have a 3500 Dx system, a simple upgrade enables you to do fragment analysis.
Overview of the 3500 Dx Genetic Analyzer (CE-IVD, IVDR)
It's accurate
The 3500 Dx Series Genetic Analyzers, using Sanger sequencing, are designed to deliver the accuracy you demand.
It's simple. It works the way you do.
Designed with you in mind, the 3500 Dx Genetic Analyzer 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
The system comes in an 8-capillary version (3500 Dx) and a 24-capillary version (3500xL Dx) to align with your throughput needs. You can run the instrument in either IVD mode or RUO mode to develop other applications, including de novo sequencing and resequencing, as well as 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.
Features & benefits
Putting you in the driver's seat
3500 Dx Data Collection Software offers user-friendly navigation and 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 contain novel integrated radio frequency identification (RFID)-tagged labels that enable viewing, tracking, and reporting of critical information
- Preformulated consumable packages contribute to the overall ease-of-use
- 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
Cathode buffer container
- IVD labeled pre-filled 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
Anode buffer container
- IVD labeled pre-filled 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
Performance optimized polymer
- IVD-labeled POP-6 polymer for sequencing and POP-7 polymer for fragment analysis are ready-to-use, load-and-run pouches.
-
Integrated RFID label enables viewing, tracking, and reporting of polymer information
Operates on standard power
The 3500 Dx Series is easy to install and operate:
- 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 |
|---|---|
Cleared for sequencing and fragment analysis in the US Approved for sequencing in Canada | An instrument that is built according to GMP to help meet your lab's compliance requirements |
| RFID | Instrument automatically checks for the use of correct product and expiration dates |
| IVD reagents/accessories | Tested and built to operate optimally with the 3500 Dx platform |
| SAE | Security, audit, and electronic signature capability to help meet compliance to governing regulations |
| 8-capillary or 24-capillary models | Select the appropriate instrument to meet your laboratory throughput needs |
| Flexibility | Both IVD and RUO modes to allow you to adhere to your lab's development requirements—sequencing or fragment analysis applications |
| IVDR Compliance | 3500 Dx series genetic analyzers are compliant with the In Vitro Diagnostic Regulation (IVDR). |
HLA typing
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer have sequencing capability for use with the SeCore HLA typing kits along with uType Dx Sequencing Analysis Software.
Fragile X syndrome and other FMR1-related disorders testing
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer have expanded fragment analysis capability for use with the AmplideX™ Fragile X Dx and Carrier Screen Kit from Asuragen, Inc.
The AmplideX Fragile X Dx and 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.
Acute myeloid leukemia testing
The Applied Biosystems 3500xL Dx Genetic Analyzer has expanded fragment analysis capability for use with the LeukoStrat™ CDx FLT3 Mutation Assay from Invivoscribe, Inc.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The assay is used as an aid in the assessment of patients with AML for whom RYDAPT™ (midostaurin) or XOSPATA™ (gilteritinib) treatment is being considered. The test is for use on the Applied Biosystems 3500xL Dx Genetic Analyzer.
Service plans
There’s no time for downtime in your lab. With more than 1,000 trained professionals ready to assist you when you need it, our service solutions for Applied Biosystems instruments and applications help keep your lab up and running.
You’re covered
Every new instrument purchase comes with a one-year warranty. Longer-term service plans are also available that include guaranteed response times* and priority phone access to our trained and certified technical and instrument support specialists. When purchased at the same time as your instrument, these services plans can help maximize system uptime, reduce overall repair costs, get fast repair turnaround time, extend the life of your instrument, and help keep it running at peak performance.
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 with preventive maintenance, proactive instrument monitoring, remote diagnostic capabilities, and—should one of your instruments require repair—a fast response.
Qualification services
Whether you need a qualification performed with a new installation or after a qualifying service event, our qualification services provide documentation to verify that your instrument is performing according to manufacturer’s specifications.
Your instruments are now easier to manage
All your instrument use and care records are now in one place—the no-cost, no-hassle Instrument Management tool. Get instant access to the complete service history of your instruments, check instrument availability, schedule instrument time from anywhere in the world, and more.
Education services help enable your success
It can be difficult to prepare yourself for what’s next while you’re focused on the work you have now. Our professional, interactive training courses make it easier. We offer a combination of virtual and in-person classroom instruction, and hands-on learning in your lab to match your schedule, budget, and learning preferences. Whichever course style you choose, you’ll learn from one of our 300 highly skilled application scientists who are available to lead sessions online, at your location, or at one of our 12 training centers located worldwide.
*Guaranteed response times are dependent on type of service plan and geographic region.
Service plan options
| AB Assurance with qualification services* | AB Assurance with performance check* | |
|---|---|---|
| On-site response time for repairs (business days) | Guaranteed 2 business days | Guaranteed 2 business days |
| Remote instrument monitoring and diagnostics | yes |  |
| Priority phone and email access to instrument support | yes | |
| Application technical support | yes | |
| Instrument operating software updates | yes | |
| Instrument qualification services | yes | |
| Planned maintenance | yes | |
| Parts, labor, and travel | yes | |
| *Terms and conditions apply. | ||
Overview of the 3500 Dx Genetic Analyzer (CE-IVD, IVDR)
It's accurate
The 3500 Dx Series Genetic Analyzers, using Sanger sequencing, are designed to deliver the accuracy you demand.
It's simple. It works the way you do.
Designed with you in mind, the 3500 Dx Genetic Analyzer 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
The system comes in an 8-capillary version (3500 Dx) and a 24-capillary version (3500xL Dx) to align with your throughput needs. You can run the instrument in either IVD mode or RUO mode to develop other applications, including de novo sequencing and resequencing, as well as 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.
Features & benefits
Putting you in the driver's seat
3500 Dx Data Collection Software offers user-friendly navigation and 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 contain novel integrated radio frequency identification (RFID)-tagged labels that enable viewing, tracking, and reporting of critical information
- Preformulated consumable packages contribute to the overall ease-of-use
- 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
Cathode buffer container
- IVD labeled pre-filled 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
Anode buffer container
- IVD labeled pre-filled 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
Performance optimized polymer
- IVD-labeled POP-6 polymer for sequencing and POP-7 polymer for fragment analysis are ready-to-use, load-and-run pouches.
-
Integrated RFID label enables viewing, tracking, and reporting of polymer information
Operates on standard power
The 3500 Dx Series is easy to install and operate:
- 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 |
|---|---|
Cleared for sequencing and fragment analysis in the US Approved for sequencing in Canada | An instrument that is built according to GMP to help meet your lab's compliance requirements |
| RFID | Instrument automatically checks for the use of correct product and expiration dates |
| IVD reagents/accessories | Tested and built to operate optimally with the 3500 Dx platform |
| SAE | Security, audit, and electronic signature capability to help meet compliance to governing regulations |
| 8-capillary or 24-capillary models | Select the appropriate instrument to meet your laboratory throughput needs |
| Flexibility | Both IVD and RUO modes to allow you to adhere to your lab's development requirements—sequencing or fragment analysis applications |
| IVDR Compliance | 3500 Dx series genetic analyzers are compliant with the In Vitro Diagnostic Regulation (IVDR). |
HLA typing
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer have sequencing capability for use with the SeCore HLA typing kits along with uType Dx Sequencing Analysis Software.
Fragile X syndrome and other FMR1-related disorders testing
The Applied Biosystems 3500 Dx Genetic Analyzer and the Applied Biosystems 3500xL Dx Genetic Analyzer have expanded fragment analysis capability for use with the AmplideX™ Fragile X Dx and Carrier Screen Kit from Asuragen, Inc.
The AmplideX Fragile X Dx and 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.
Acute myeloid leukemia testing
The Applied Biosystems 3500xL Dx Genetic Analyzer has expanded fragment analysis capability for use with the LeukoStrat™ CDx FLT3 Mutation Assay from Invivoscribe, Inc.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The assay is used as an aid in the assessment of patients with AML for whom RYDAPT™ (midostaurin) or XOSPATA™ (gilteritinib) treatment is being considered. The test is for use on the Applied Biosystems 3500xL Dx Genetic Analyzer.
Service plans
There’s no time for downtime in your lab. With more than 1,000 trained professionals ready to assist you when you need it, our service solutions for Applied Biosystems instruments and applications help keep your lab up and running.
You’re covered
Every new instrument purchase comes with a one-year warranty. Longer-term service plans are also available that include guaranteed response times* and priority phone access to our trained and certified technical and instrument support specialists. When purchased at the same time as your instrument, these services plans can help maximize system uptime, reduce overall repair costs, get fast repair turnaround time, extend the life of your instrument, and help keep it running at peak performance.
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 with preventive maintenance, proactive instrument monitoring, remote diagnostic capabilities, and—should one of your instruments require repair—a fast response.
Qualification services
Whether you need a qualification performed with a new installation or after a qualifying service event, our qualification services provide documentation to verify that your instrument is performing according to manufacturer’s specifications.
Your instruments are now easier to manage
All your instrument use and care records are now in one place—the no-cost, no-hassle Instrument Management tool. Get instant access to the complete service history of your instruments, check instrument availability, schedule instrument time from anywhere in the world, and more.
Education services help enable your success
It can be difficult to prepare yourself for what’s next while you’re focused on the work you have now. Our professional, interactive training courses make it easier. We offer a combination of virtual and in-person classroom instruction, and hands-on learning in your lab to match your schedule, budget, and learning preferences. Whichever course style you choose, you’ll learn from one of our 300 highly skilled application scientists who are available to lead sessions online, at your location, or at one of our 12 training centers located worldwide.
*Guaranteed response times are dependent on type of service plan and geographic region.
Service plan options
| AB Assurance with qualification services* | AB Assurance with performance check* | |
|---|---|---|
| On-site response time for repairs (business days) | Guaranteed 2 business days | Guaranteed 2 business days |
| Remote instrument monitoring and diagnostics | yes | |
| Priority phone and email access to instrument support | yes | |
| Application technical support | yes | |
| Instrument operating software updates | yes | |
| Instrument qualification services | yes | |
| Planned maintenance | yes | |
| Parts, labor, and travel | yes | |
| *Terms and conditions apply. | ||
Ordering information
| Catalog # | Name | |
| A46344 | Applied Biosystems 3500 Dx Genetic Analyzer (8-capillary) | Request for quote › |
| A46345 | Applied Biosystems 3500xL Dx Genetic Analyzer (24-capillary) | Request for quote › |
For In Vitro Diagnostic Use.