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 quantitative PCR system, designed to help you get to your clinical answers quickly by fitting seamlessly into your workflow. This compact, flexible system helps provide confidence in performance and maximizes benchtop space.
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Powered by proven technology, the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a standalone qPCR platform that is versatile, highly expandable, and easy to use. Designed to support in vitro diagnostic (IVD) applications, the QuantStudio 7 Pro Dx system incorporates smart features such as hand-free functionality. Whether your laboratory is running routine assays or developing new ones, the QuantStudio 7 Pro Dx can support your work.
With sensitivity down to 1.5-fold in singleplex reactions and 10 logarithmic units of linear dynamic range, the QuantStudio 7 Pro Dx system supports the development of molecular diagnostic (MDx) assays. The compact footprint, software features, and up to six-color multiplexing helps enable laboratory productivity and innovation.
Please check with your sales representative for availability of this product in your region.
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).
*3500 Dx RUO mode is For Research Use Only. Not for use in diagnostic procedures.
The Applied Biosystems VeritiPro Dx Thermal Cycler is an in vitro diagnostic (IVD) endpoint thermal cycler designed to amplify nucleic acids from human-derived specimens using polymerase chain reaction (PCR). VeritiPro Dx Thermal Cycler conforms to EU 2017/746 requirements and is CE-IVD labeled in Europe. It is classified as a US-FDA class I medical device.
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 easy setup and tube strips for lower-throughput runs, the instrument enables assay development* on the same in vitro diagnostic instrument.
*7500 Fast Dx assay development workflow is For Research Use Only. Not for use in diagnostic procedures.
The GeneChip System (GCS) 3000Dx is an IVD microarray system for RNA- and DNA-based clinical tests. It is the foundation of the expanding Affymetrix Clinical Toolkit.
For In Vitro Diagnostic Use.
*Torrent Suite™ Assay Development Software is For Research Use Only, and not for use in diagnostic procedures.