Sequenom submits FDA application for thrombophilia test

10/4/2013 | GenomeWeb Daily News (free registration)

Sequenom has submitted a 510(k) clearance application for its Impact Dx Factor V Leiden and Factor II Genotyping Test as well as its Impact Dx System to the FDA. The Impact Dx Factor V Leiden and Factor II Genotyping Test, designed to screen patients for thrombophilia, will be used in conjunction with the Impact Dx System. The assay and system are tailored for use in clinical labs.

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