510(k) Report

Devices descending from K243813

2 later devices reach QIAstat-Dx GI Panel 2 Mini B&V 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—
+2K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20260—