Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

QIAGEN GmbH

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262168 QIAstat-Dx BCID GN Plus AMR PanelPEN2026-09-24 View
510(k) K254194 QIAstat-Dx BCID GPF Plus AMR PanelPAM2026-08-06 View
510(k) K254032 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BPCH2026-03-09 View
510(k) K252329 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BPCH2025-10-22 View
510(k) K250080 QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF2025-08-27 View
510(k) K250324 QIAstat-Dx GI Panel 2 Mini BPCH2025-02-28 View
510(k) K243813 QIAstat-Dx GI Panel 2 Mini B&VPCH2025-01-08 View
510(k) K242256 QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO2024-10-29 View
510(k) K242353 QIAstat-Dx Respiratory Panel MiniQOF2024-10-25 View
510(k) K220062 QIAstat-Dx Gastrointestinal Panel 2PCH2024-05-31 View
510(k) K233100 QIAstat-Dx® Respiratory Panel PlusQOF2024-05-10 View
510(k) K183597 QIAstat-Dx Respiratory PanelOCC2019-05-18 View
510(k) K113319 ROTOR-GENE Q MDXOOI2012-02-06 View
510(k) K113323 ARTUS INFL A/B RG RT-PCR KITOCC2012-02-06 View
↑