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# BioFire EUA Revoked After De Novo Granted
- URL: https://www.fdaweb.com/biofire-eua-revoked-after-de-novo-granted/
- Published: 2021-05-28T12:00:00.000Z
- Updated: 2026-09-14T17:01:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149430

*Federal Register* notice: FDA has revoked a BioFire Diagnostics emergency use authorization for its BioFire Respiratory Panel 2.1 after the company was granted a De Novo classification marketing order for the device. To view the notice, click [here](https://webmail.emailsrvr.com/a/webmail.php?wsid=d9caa8725ab041408a98d28ebccedd86-8d706dd4c3544b98aa9572ad3341373d&ref=fdaweb.com).