MARCH 7, 2025

FDA Clears Second QIAstat-Dx Mini GI Rapid Diagnostic Test

By IDSE News Staff

The FDA cleared Qiagen’s QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

This marks Qiagen’s second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.

This newly cleared panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing