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Home » Werfen Gains CE Mark for Aptiva Reagent for Autoimmune Disease Testing
Werfen Gains CE Mark for Aptiva Reagent for Autoimmune Disease Testing
Werfen has received a CE mark for its Aptiva CTD (connective-tissue disease) reagent for use on the Aptiva lab system, an automated, high-throughput system that enables clinical laboratories to process multiple analytes simultaneously from a patient sample.
Aptiva, which will initially test for several autoimmune diseases, has more than 60 analytes in various stages of advanced development, the company said.
San Diego, Calif.-based Inova Diagnostics, a Werfen subsidiary, gained 510(k) clearance from the FDA for the Aptiva system in June.
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