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# FDA Grants De Novo for Covid Diagnostic
- URL: https://www.fdaweb.com/fda-grants-de-novo-for-covid-diagnostic/
- Published: 2021-03-18T12:00:00.000Z
- Updated: 2026-09-14T16:51:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148918

FDA has granted BioFire Diagnostics a De Novo marketing authorization for the [BioFire Respiratory Panel 2.1 (RP2.1)](https://www.accessdata.fda.gov/cdrh%5Fdocs/pdf20/DEN200031.pdf?ref=fdaweb.com), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of Covid-19 and other respiratory tract infections. The diagnostic test was previously granted an emergency use authorization (EUA), and it is the first Covid-19 diagnostic to go through one of the agency’s traditional premarket authorities, an [agency release](https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process?ref=fdaweb.com) says. The *De Novo* request for the test was based on additional data showing validation beyond what is needed for an EUA, FDA says.

“We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities,” acting FDA commissioner **Janet Woodcock** is quoted in the release as saying. “While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways.”