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# FDA Approves Grifols Zika Virus Assay
- URL: https://www.fdaweb.com/fda-approves-grifols-zika-virus-assay/
- Published: 2018-08-15T12:00:00.000Z
- Updated: 2026-09-15T00:25:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142119

FDA has approved Grifols’ Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors and cell- and tissue-based products. The assay has been in use since 6/2016 under an IND. It is performed on the Procleix Panther system automated platform using nucleic acid technology, according to the company.