Accurate and trusted IVD solutions for genetic analysis
Our genetic analysis instruments support your lab’s assay development needs along with a workflow to match your diagnostic requirements.
The Ion PGM™ Dx System delivers the speed and simplicity of the Ion Torrent™ platform, combined with key workflow advantages designed specifically for regulated laboratory environments and in vitro diagnostic applications. Now with combined functions software* to enable maximum utility for clinical research.
The QuantStudio 5 Dx Real-Time PCR System, an IVD approved (CE-IVD and US-IVD) quantitative PCR system, is designed to help you get to your clinical answers quickly by fitting seamlessly into your diagnostic workflow and validated protocols. This compact, flexible system provides confidence in performance and supports both development and IVD modes, offering an ideal solution for test developers as well.
The QuantStudio™ Dx Real-Time PCR Instrument offers your clinical laboratory performance you can rely on in a Fast 96-well diagnostic platform, as well as provides the flexibility your lab needs to grow with additional formats. The QuantStudio Dx instrument can be operated in either IVD mode or Test Development mode (for assay development).
The Applied Biosystems™ 3500 Dx Genetic Analyzer provides laboratories with a reliable, versatile, and innovative tool for molecular diagnostic testing. Based on Sanger sequencing, one of the most widely used, widely trusted sequencing methodologies available, the 3500 Dx Genetic Analyzer can be operated in either IVD mode (for diagnostic HLA typing using SeCore™ HLA typing kits) or RUO mode (to develop other applications).
The Applied Biosystems Veriti™ Dx PCR Thermal Cycler provides the reliability of Applied Biosystems 9600 and GeneAmp™ systems in an IVD instrument. It features a powerful color touch screen to simplify instrument setup and provides precise control for PCR optimization, the ability to run six different thermal cycling profiles at once, and both Fast and standard PCR modes.
The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument is designed to deliver the performance required for high-quality results. Accommodating both 96-well plates for easier setup and tube strips for lower-throughput runs, the instrument enables assay development and validation projects on the same in vitro diagnostic instrument.
The GeneChip™ System (GCS) 3000Dx is a US IVD and CE-marked microarray system for RNA- and DNA-based clinical tests. It is the foundation of the expanding Affymetrix Clinical Toolkit that includes the Gene Profiling Array cGMP U133 P2, which is the cGMP-manufactured version of the widely cited GeneChip Human Genome U133 Plus 2.0 Array.
For In Vitro Diagnostic Use.
*Torrent Suite™ Assay Development Software is For Research Use Only, and not for use in diagnostic procedures.