Health and Human Services Department Docket FDA-2026-N-1309 Notice

2026-03250: Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability

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Summary

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to ExThera Medical Corporation, for the Seraph 100 Microbind Affinity Blood Filter (Seraph 100). FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.

The agency’s own summary, as published.

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