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Medical Devices / Submissions and Approvals

Procleix’s Zika Assay Earns FDA Approval for Use With Panther System

Aug. 15, 2018

The FDA approved Procleix’s Zika virus assay for blood screening on Procleix’s Panther system.

The assay is approved for detecting the Zika virus in donated individual or pooled plasma specimens, making it useful for blood banks in their efforts to screen blood donations for the virus.

It is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products.

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