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, meaning that Tecan is leading the field in its rapid implementation of the new regulations.
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.
Mark Wang, chief representative of Tecan China, explained: "Tecan is well equipped to serve customers in China, with a permanent office in Beijing established in 2005, as well as a strong distribution network and nine highly trained application specialists to support the customer base".
The Freedom Evolyzer has been designed to comply with the 98/79/EC directive on in vitro diagnostic medical devices.
The workstation already has plenty of satisfied customers in Europe, offering a wide range of automation options for all typical Elisa steps, including sample distribution, reagent pipetting, incubation, washing, reading and data generation.
The new Freedom Evolyzer software version 1.5, released in July 2006, includes improved error handling, more flexible scheduling and 20 per cent faster pipetting capabilities.
Not all applications discussed in this press release have been cleared for use in all countries.
Contact your local sales office for specific information.
