Trade Release – Randox RX daytona+ (FDA) 510 (K) Clearance
Randox RX daytona+ (FDA) 510 (K) Clearance
Randox Laboratories a world leader in the in-vitro diagnostic industry with over 35 years’ experience is pleased to announce 510K clearance from the U.S. Food and Drug Administration for the RX daytona+ clinical chemistry analyzer. Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, diabetes and veterinary testing. Guaranteeing real cost savings through consolidation of routine and specialized tests onto a single platform, the RX series of analyzers offers excellence in patient care, delivering unrivalled precision, accuracy and reliability.
The RX daytona+ fully automated, benchtop, clinical chemistry analyzer is capable of performing high quality testing including emergency STAT sampling and boasts a combined throughput of 450 tests per hour including ISE. The most versatile chemistry analyzer in its class, the RX daytona+ presents laboratories with a range of benefits offering optimum performance, unrivalled uptime, flexibility, efficiency and functionality.
Randox have a long history of being at the forefront of diagnostic testing and have brought to market a range of innovative and versatile clinical chemistry analyzers developed to revolutionize patient testing in a variety of laboratory types including; Clinical Laboratories, University & Research Institutes, Veterinary Laboratories and Food & Wine Laboratories. The capabilities of the RX daytona+ exceed in any laboratory setting regardless of size, boasting an array of innovative features, including a significant reduction in sample volume of just 1.5-35 µl with a sample dead volume of 150 µl for standard and 100 µl for pediatric samples.
The RX daytona+ presents excellent functionality with easy to use Windows 10 based software, minimal maintenance and advanced QC capabilities generating Levey-Jennings charts, calibration curves and QC statistics all contributing to the increased precision, accuracy and reliability the RX series is famed for. As a performance advantage, the RX daytona+ provides laboratories with the ability to consolidate a wide variety of routine and specialized tests onto a single platform with excellent correlation to gold standard methodologies. Providing laboratories globally with efficiencies in time, money, ease of use, unrivalled uptime and superior technical support, the RX daytona+ is the most advanced and versatile clinical chemistry analyzer available.
Timothy Lenz – Regional Sales Manager USA
“The RX Daytona+ receiving FDA 510K clearance will provide a much-needed addition to the US clinical laboratory market. The RX Daytona+ serves the needs of lower throughput, moderate complexity labs, while still offering many of the features found on larger floor-standing analyzers – full automation, ability to process bar-coded samples in primary tubes, variable speed paddle mixers, and dedicated sample and reagent probes, all on a versatile platform with low operating costs and maintenance requirements. The high-quality construction of the RX Daytona+ ensures an incredibly reliable platform with the lowest downtime figures in its class. The wide testing menu of the RX Daytona+ allows labs to bring additional profitable testing in-house, so that results can be returned more quickly, and diagnoses/treatment plans formulated without delay. Randox is the only company that can truly provide a single-vendor solution for clinical chemistry testing – reliable analyzers, dedicated reagents, and third-party QC materials, all from the same provider.”
About Randox Laboratories
As a world leader in the in-vitro diagnostic industry with over 35 years’ experience, Randox is leading the charge in moving from a one-size-fits-all approach towards decisions, practices and products tailored to the needs of the individual. This innovative approach to diagnostics has facilitated the development of revolutionary products designed specifically to enhance a patients’ quality of life.
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