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Medical Devices / Submissions and Approvals

FDA Clears Agilent’s GenetiSure Dx Postnatal Assay

Sept. 19, 2017
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Agilent Technologies received 510(k) marketing clearance for the GenetiSure Dx Postnatal Assay, the company’s first comparative genomic hybridization assay for diagnostic use.

The device enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features.

The device is intended for use on the Agilent SureScan Dx microarray scanner system, a Class II exempt medical device.

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