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