FDA grants Illumina 510(k) clearance for VeraCode Genotyping Test for Factor V and Factor II

Illumina, Inc. (NASDAQ:ILMN) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for the VeraCode® Genotyping Test for Factor V (Leiden) and Factor II (Prothrombin).

The VeraCode Genotyping Test is comprised of the company's VeraCode digital microbead technology and proprietary assay chemistry. The BeadXpress® System, which received a separate 510(k) market clearance, is FDA-cleared for in vitro diagnostic use only with the VeraCode Genotyping Test for Factor V and Factor II.

Source Illumina

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