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Qiagen Receives FDA Clearance for Gastrointestinal Panel Tests
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Qiagen Receives FDA Clearance for Gastrointestinal Panel Tests
Jan 9, 2025 2:05 PM

04:33 PM EST, 01/09/2025 (MT Newswires) -- Qiagen ( QGEN ) said the US Food and Drug Administration approved QIAstat-Dx Gastrointestinal Panel tests for clinical use.

The clearance covers QIAstat-Dx Gastrointestinal Panel 2 Mini bacterial and viral to identify five causes of gastrointestinal disease, the company said Thursday in a statement.

The company expects to file a second version of the panel covering common bacterial pathogens that cause gastrointestinal infections with the FDA for approval in the coming weeks.

Qiagen ( QGEN ) intends to submit an application for FDA clearance for a higher-capacity diagnostic instrument, QIAstat-Dx Rise, in early 2025.

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