SIRS-Lab Receives ISO Certification for Molecular In-vitro Sepsis Diagnostics

SIRS-Lab have announced its Quality Management certification for in-vitro diagnostics. After building up a new production suite, the company now accelerates the further clinical routine implementation of its molecular diagnostic tests for sepsis.

The in-vitro diagnostics certification is the official approval for the production of medical devices according to European clinical diagnostic regulations. In a preparation and auditing process of six months, SIRS-Lab has demonstrated highest standards for security and transparency in operations. The company expects a significant momentum for the commercialization of its diagnostic suite composed of two unique products VYOO and SIQNATURE.

The sepsis pathogen detection test VYOO is available for purchase since December 2007. SIQNATURE, the test for the early identification of sepsis and immune monitoring of patients at risk, is currently accessible for selected scientific experts. This unique new standard in sepsis diagnostics will be fully available in 2009.

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Source : SIRS-Lab GmbH View archived contact details

Posted on October 21, 2008