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

From Illumina, Inc.May 19 2010

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

Posted in: Device / Technology News | Medical Science News

Tags: Assay, Biotechnology, Diagnostic, Factor V Leiden, Food, Gene Expression, Genomics, Genotyping, Illumina, in vitro, Proteomics, Technology

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Illumina, Inc.. (2018, July 27). FDA grants Illumina 510(k) clearance for VeraCode Genotyping Test for Factor V and Factor II. News-Medical. Retrieved on October 31, 2024 from https://www.news-medical.net/news/20100519/FDA-grants-Illumina-510(k)-clearance-for-VeraCode-Genotyping-Test-for-Factor-V-and-Factor-II.aspx.
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Illumina, Inc.. "FDA grants Illumina 510(k) clearance for VeraCode Genotyping Test for Factor V and Factor II". News-Medical. 31 October 2024. <https://www.news-medical.net/news/20100519/FDA-grants-Illumina-510(k)-clearance-for-VeraCode-Genotyping-Test-for-Factor-V-and-Factor-II.aspx>.
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Illumina, Inc.. "FDA grants Illumina 510(k) clearance for VeraCode Genotyping Test for Factor V and Factor II". News-Medical. https://www.news-medical.net/news/20100519/FDA-grants-Illumina-510(k)-clearance-for-VeraCode-Genotyping-Test-for-Factor-V-and-Factor-II.aspx. (accessed October 31, 2024).
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Illumina, Inc.. 2018. FDA grants Illumina 510(k) clearance for VeraCode Genotyping Test for Factor V and Factor II. News-Medical, viewed 31 October 2024, https://www.news-medical.net/news/20100519/FDA-grants-Illumina-510(k)-clearance-for-VeraCode-Genotyping-Test-for-Factor-V-and-Factor-II.aspx.