The QuantStudio™ Dx Real-Time PCR Instrument is a real-time PCR platform that delivers the proven performance, flexibility, expandability, and support needed to meet the evolving needs of the clinical laboratory today and tomorrow. The QuantStudio™ Dx instrument is approved for in vitro diagnostic (IVD) use with the Quidel® Molecular Direct C. difficile Assay, the first available from a growing menu of assays that are under development. In Test Development Mode, the QuantStudio™ Dx Real-Time PCR Instrument offers easy-to-change blocks that can also accommodate array cards, as well as 96-well standard, 96-well Fast, and 384-well plates, allowing you to select the format that is right for your throughput needs.
Built on a legacy of innovation and excellence in real-time PCR, the QuantStudio™ Dx instrument leverages the best of Life Technologies' portfolio of Applied Biosystems® real-time PCR systems, and refines a platform to specifically meet the needs of the diagnostic laboratory.
Results You Can Trust
The QuantStudio™ Dx Real-Time PCR Instrument's proven performance, security, and reliability—combined with the outstanding sensitivity and specificity of the Quidel® Molecular Assays—help ensure the right answer is delivered the first time, every time.
Flexibility You Want, Security You Need
In Test Development Mode, The QuantStudio™ Dx Real-Time PCR Instrument with the 96-Well fast Block is designed with easily interchangeable thermal cycling blocks to accommodate your laboratory's varying needs for throughput, format type, and assay type. In addition to the 96-well fast format that was cleared for use in the US with the Quidel Molecular Direct C. difficile Assay, the instrument also accepts 96-well standard, 384-well, and array card formats that can be used in Test Development Mode for assay development.
Efficient Workflows and Assays
A simplified instrument and assay workflow, as well as intuitive software, make the entire test easy and efficient, from processing to reporting. Plus, it frees up highly trained operators to perform more complex tasks.
QuantStudio™ Dx Software
• Track reagent and patient information for quality control purposes
• Enter reagent information by barcode and upload patient information from Excel files to minimize data entry errors
• Print calibration and maintenance reports for your instrument records
• Included SAE module assists with Security, Auditing, and Electronic signature of records for full data traceability as part of 21 CRF Part 11 compliance
For In Vitro Diagnostic Use. The QuantStudio™ Dx Real-Time PCR Instrument meets the requirements of the in vitro Diagnostic Medical Devices Directive (98/79/EC). The CE IVD-registered QuantStudio™ Dx Real-Time PCR Instrument is for distribution and use in specific countries only.