Swiss-based Tecan has successfully registered its automated ELISA analyser, the Freedom EVOlyzer, with the State Food and Drug Administration (SFDA) in China.
New Chinese National Standards for medical electrical equipment were introduced in May 2006 and the Freedom EVOlyzer is one of the first clinical devices to become SFDA-compliant.
Seven Freedom EVOlyzer workstations were immediately ordered for customers in China following the registration. The instrument's high speed, flexibility and walkaway features are proving to be particularly important for hospitals and blood bank laboratories, and the automated ELISA platform is currently unrivaled in China, says Tecan.
The Freedom EVOlyzer has been designed to comply with the 98/79/EC directive on in vitro diagnostic medical devices. The workstation offers a wide range of automation options for all typical ELISA steps, including sample distribution, reagent pipetting, incubation, washing, reading and data generation. The new software version 1.5, released in July 2006, includes improved error handling, more flexible scheduling and 20% faster pipetting capabilities.
