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Procleix Zika Virus Assay

GRIFOLS DIAGNOSTIC SOLUTIONS INC. · Model 5K Kit Box 3 · UDI-DI 00859882007658

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510(k) clearances
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Description

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from human donors.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.