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# EUA Revoked After 510(k) Cleared on Zika Assay
- URL: https://www.fdaweb.com/eua-revoked-after-510-k-cleared-on-zika-assay/
- Published: 2020-07-24T12:00:00.000Z
- Updated: 2026-09-14T16:22:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147276

*Federal Register* notice: FDA has revoked the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Assay System because the company obtained premarket notification clearance for the device and related accessories. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-07-24/pdf/2020-16014.pdf?ref=fdaweb.com).