510(k) Report

Devices descending from K220062

4 later devices reach QIAstat-Dx Gastrointestinal Panel 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20251—
+1K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH20252—
+1K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH20252—
+2K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20260—