Certificate

Brand

Thermo Fisher Scientific

Product Type

Instrument

Highlights

ISO 13485:2016

Designed to meet the in vitro diagnostic regulation (IVDR) requirements for higher quality and safety for medical devices, the Applied Biosystems™ QuantStudio™ 5 Dx
Real-Time PCR System fits seamlessly into your established workflow so you can get up and running quickly. You will benefit from its compact footprint and ease of use as
well as its industry-leading technology, which includes enhanced cybersecurity
Application
Premium performance at an affordable price
• Future proof—updated to meet IVDR and technical documentation requirements
• Results you can trust—detect differences in target quantity as small as 1.5-fold in singleplex reactions, and obtain 10 logarithmic units of linear dynamic range
• Simple, powerful software—allows users to set up a run, lay out assays, control the instrument, and conduct plate analysis within a single, easy-to-use software interface
• Efficient—interactive diagnostic instrument with short run times, minimal maintenance, and use of existing plastic consumables
• Enhanced security—security, auditing, and e-signature (SAE) functionalities that assist with compliance plus the ability to support multiple clients; maintain centralized SAE settings that can be applied to multiple instruments on the same network, allowing better control for your IT department
• Peace of mind—IVD test menu allows only authorized IVD tests to be run through IVD mode, helping to reduce the risk of unauthorized use and accidental or intentional misuse
• Flexibility you need—diagnose or develop, the choice is yours with software options that guide you through every step of test development and IVD modes
• Maximize benchtop space—compact instrument
• Superior support—support available globally from highly skilled, customer-focused staff
• QuantStudio system qPCR performance—the reliability, sensitivity, and accuracy you expect, coupled with an intuitive and simple-to-use interface that allows users of any
experience level to operate the system with ease
Specifications

Technical specifications
Reaction volume 96-well, 0.2 mL block: 10–100 μL
Excitation source: Bright-white LED
Optical detection: 6 decoupled filters, CMOS camera
Excitation/detection range: 450–680 nm/500–730 nm
Temperature range: 4–99.9°C
Maximum block ramp rate: 6.5°C/sec
Average sample ramp rate: 3.66°C/sec
Temperature uniformity: 0.5°C
Temperature accuracy: 0.25°C
Heating and cooling method: Peltier
Independent temperature zones: 6 VeriFlex™ zones (5°C zone-to-zone)
Chemistries: Both fast and standard
Run times: <30 min (fast mode)
Validated reaction volumes: 10–100 µL
Factory-calibrated dyes: FAM™, SYBR™, VIC™, ABY™, NED™, TAMRA™, JUN™, ROX™, Mustang Purple™, and Cy®5 dyes
Multiplex 5-plex with 1 passive reference; 6-plex with no passive reference
Sensitivity: 1 copy; detects differences as small as 1.5-fold in target quantities in singleplex reactions
Dynamic range: 10 logarithmic units of linear dynamic range
Security and auditing features
• Integrated tools to assist with compliance
• The audit function is always enforced in IVD mode, but optional for the test development modeto tailor for different traceability needs

Other information
Block Format: Non-interchangeable
Format: 96-well, 0.2 mL
Automation compatible: No
Footprint (H x W x D): 40 x 27 x 50 cm
Weight: 27 kg
CE-IVD certification IVDR complian

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