Thermo Fisher Scientific has updated its Applied Biosystems 3500 and 3500xL DX genetic analyzers to comply with IVDR regulations.

The Thermo Fisher Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzers are mid-throughput capillary electrophoresis (CE)-based in vitro diagnostic devices designed to perform fluorescence-based sequencing and fragment analysis of nucleic acids in human-derived specimens.

The IVDR-compliant versions of both analyzers and corresponding consumables are now available in the majority of EU territories as hospitals, clinical testing labs, and molecular diagnostic manufacturers adapt to new regulations.

Key features of the analyzers include:

  • High flexibility: Dual mode (IVD and RUO) capability to fulfill labs’ development requirements for sequencing or fragment analysis applications.  
  • Availability in two models: Eight-capillary (3500 Dx) and 24-capillary  
    (3500xL Dx) provide flexibility to align with labs’ throughput needs. 
  • Easy-to-install consumables: Primary consumables contain novel integrated radio frequency identification (RFID)-tagged labels that enable viewing, tracking, and reporting of critical product information such as expiration dates. 
  • Ease of use: 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 and convenient maintenance scheduling calendar.

Thermo Fisher Scientific says its mission is to enable its customers to make the world healthier, cleaner, and safer by providing solutions that help with productivity in their laboratories, improving patient health through diagnostics, or via the development and manufacture of life-changing therapies.