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# FDA Clears Qiagen’s Respiratory Panel Plus
- URL: https://www.fdaweb.com/fda-clears-qiagens-respiratory-panel-plus/
- Published: 2024-05-14T12:00:00.000Z
- Updated: 2026-09-14T14:30:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156975

FDA has cleared a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respiratory infections and covers 21 viral and bacterial targets. It was previously authorized under an emergency use authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel. “The panel leverages QIAstat-Dx’s ability to quickly amplify many genetic targets at once using real-time PCR technology, delivering results in about one hour and with less than one minute of hands-on time,” the company says. “Cycle threshold values and amplification curves are easily viewable and provide healthcare professionals with additional clinical information.”

Qiagen says it is working on expanding its portfolio for QIAstat-Dx in the U.S., with a gastrointestinal panel currently under FDA review and a meningitis/encephalitis panel.