Focus on diagnostics, streamline your workflow
The Applied Biosystems SeqStudio Flex Dx Genetic Analyzer is an IVDR-compliant capillary electrophoresis (CE) system designed to meet the needs of clinical laboratories by offering compliance, efficiency, ease of use, and flexibility.
With the same trusted technology of the Applied Biosystems 3500 Dx Genetic Analyzer, the SeqStudio Flex Dx Genetic Analyzer offers even more innovation with three operating modes For In Vitro Diagnostic Use (IVD), For Investigational Use Only and For Use in Performance Evaluation Studies (IUO), and For Research Use Only (RUO). The system also offers laboratory information management system (LIMS) compatibility, increased data quality, and more intuitive design and time savings features.
Stay aligned with the latest IVDR regulatory mandates with the easy-to-use, IVDR-compliant, SeqStudio Flex Dx Genetic Analyzer.
Instrument highlights
The SeqStudio Flex Dx Genetic Analyzer helps achieve regulatory compliance with an intuitive design and streamlined operation, all while enabling fast, accurate results.
Ready-to-go Dx system
- IVDR-compliant system with validated IVD on-instrument consumables to enable a seamless IVD workflow
- RUO, IUO, and IVD modes for ability to move from development and validation, investigational use, and diagnostic testing
- Integrated with the security, auditing, and e-signature (SAE) Dx module
Increased sample loading and run flexibility
- Four-plate capacity, continuous plate loading, and urgent sample reprioritization allows complete scheduling flexibility, translating into extra time in your day
- Remote plate setup, run monitoring, and data transfer allows users to stay connected to their instrument and data, remotely and safely, from anywhere
- 8- and 24-capillary configurations
More seamless IVD assay development
The SeqStudio Flex Dx open system allows users to create injection protocols with factory-provided or custom library objects and publish a validated injection protocol from RUO mode for use in IVD mode. Plus, users can create and use custom dye sets for even more flexibility.
Enhanced productivity with remote troubleshooting
Smart Help and Remote Support capabilities help reduce instrument downtime and resolve up to 70% of issues though real-time virtual collaboration tools.
Ease of use
- Easy capillary array installation with automatic spectral calibration capabilities
- Streamlined one-button startup
- Onboard learning center offer users of any skill level greater usability and streamlined training
Advanced communications and connectivity
- LIMS integration capable
- The latest communication technologies, such as voice commands, a wide array of connectivity options, and the latest Windows™ software to stay up to date with latest cybersecurity updates
Applications
The SeqStudio Flex Dx Genetic Analyzer is indicated for sequencing and fragment analysis by trained personnel in a professional laboratory environment in combination with in vitro diagnostic assays.
3500 Dx comparison
With the same trusted technology of the Applied Biosystems 3500 Dx Genetic Analyzer, the SeqStudio Flex Dx analyzer offers even more innovation with IVD, IUO, and RUO modes, LIMS compatibility, increased data quality, plus more intuitive design and time savings features, built with scientists in mind.
See how upgrading to a SeqStudio Flex Dx Genetic Analyzer can benefit your lab:
| SeqStudio Flex Dx Genetic Analyzer | 3500 Dx Genetic Analyzer | |
|---|---|---|
| Number of capillaries | 8 or 24 | 8 or 24 |
| Operating modes | IVD, IUO, RUO | IVD, RUO |
| IVD validated consumables | Polymers (POP-6, POP-7), arrays, and buffers | Polymers (POP-6, POP-7), arrays, and buffers |
| Sample capacity | Four plates—run up to seven plates in an 8-hour workday | Two plates—run up to five plates in an 8-hour workday |
| Continual plate loading | Yes—no more sample batching | No |
| Configuration and start-up | Integrated computer with touchscreen and simple push-button start. External computer is required for SAE. | No integrated computer. External desktop required for instrument operation. Multiple steps to power up. |
| Remote monitoring, plate setup, and data sharing | Yes—set up plate, monitor run, and share data remotely | No |
| Onboard videos and wizards | Yes—offer easy-to-follow steps, even for new users | No |
| Remote troubleshooting | Yes—resolve up to 70% of issues remotely | No |
| Off-scale recovery algorithm | Yes—get up to two times more data than the peak height of the 3500 analyzer | No |
| Capillary array | Redesigned array for easier insertion/removal plus automatic spectral calibration capabilities | No auto-calibration and more finicky array installation |
| Open system for development, validation, and distribution of IVD assays | Yes—publish injection protocols from RUO mode to IVD mode upon regulatory body approval | Capability depends on country |
Service and support
When it comes to superior services and support for your SeqStudio Flex Dx Genetic Analyzer, we’ve got your back. Maximize system uptime, reduce repair costs and turnaround time, extend the life of your instrument, and help keep it running at peak performance with one of our comprehensive service plans.
Our most popular plan, the AB Assurance Dx Plan, helps take the guesswork out of instrument uptime, from issue prevention to resolution of performance-threatening issues, so you can stay focused on the important work ahead of you.
Find out more about the AB Assurance Dx service plan at thermofisher.com/abassurancedx.
Qualification services
The Services and Support team at Thermo Fisher Scientific knows Applied Biosystems instruments better than anyone. With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to the manufacturer’s specifications. Our trained and certified field service engineers will conduct comprehensive tests, including software and hardware compatibility, component verification, and site requirements, to verify performance and provide reliable, audit-style documentation to support regulatory requirements.
Operating modes
The SeqStudio Flex Dx Genetic Analyzer supports three instrument operating modes: For Research Use Only (RUO), For Investigational Use Only and For Use in Performance Evaluation Studies (IUO), and For In Vitro Diagnostic Use (IVD).
- RUO mode—supports iterative changes to the assay definition during the assay development phase
- IUO mode—supports verification and validation runs for product development
- IVD mode—supports routine testing for IVD tests
Note: The IUO mode allows users to install IUO injection protocols intended for investigational use only or for use in performance evaluation studies. The IUO mode is disabled by default. The instrument must be configured for IUO mode by the service team from Thermo Fisher Scientific. If the instrument has not been configured for IUO mode, the IUO option is not available.
Specifications and ordering information
| Attribute | Description |
|---|---|
| Number of capillaries | 8 or 24 |
| Capillary array | 50-cm Dx capillary arrays in IVD mode |
| Number of dyes | 6 dyes |
| Capacity | 4-plate capacity, 96-well plates in IVD mode |
| Dimensions (W x D x H) | 70 x 67.5 x 86.5 cm (27.6 x 26.6 x 34.1 in) |
| Weight | 115 kg (253.5 lb) |
| Power input | 100–240 V |
| Internal hard drive | 512-GB solid-state drive (SSD) |
| Excitation source | 505-nm solid-state laser |
| On-instrument tracking | Radio frequency identification (RFID), internal barcode reader |
| On-instrument consumables validated for IVD mode | Polymers (POP-6 and POP-7), arrays, and buffers |
| Open system for development, validation, and distribution of IVD assays |
|
| Communication interface | Connect cloud-based platform; USB port for Wi-Fi dongle; 3 RJ-45 ethernet ports |
| Configuration | Stand-alone; SAE requires external computer |
| Warranty | Standard one-year warranty included; extended warranties available |
| SmartStart orientation | Includes one day onsite training by a field application specialist |
| Remote troubleshooting | Smart Help and Smart Remote Support capabilities enable fast and effective resolution of instrument issues for reduced instrument downtime |
| Remote monitoring, plate setup, and data sharing | Set up plate, monitor run, and share data remotely |
Skus Requested: A40003721,A40003722,A40003723,A40003720,A40003956,A40003959,A40003958,A40003957
Skus Returned by ms service:
For In Vitro Diagnostic Use.
Only available for sales in the following countries: Italy, France, Germany, Spain, UK, Austria, Czech Republic, Belgium, Sweden, Norway, Denmark, Poland, Ireland, Netherlands, Luxembourg, Oman