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QIAGEN GmbH

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories6
Latest FDA decision2026-08-06
TypeNumberDevice NameCodeDateActions
510(k) K254194 QIAstat-Dx BCID GPF Plus AMR PanelPAM2026-08-06 View
PMA P180043 Somatic gene mutation detection systemOWD2026-05-06 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
PMA P190001 Somatic gene mutation detection systemOWD2025-10-22 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
PMA P110027 Somatic gene mutation detection systemOWD2025-01-16 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
PMA P210002 Somatic gene mutation detection systemOWD2023-06-29 View
PMA P190026 Somatic gene mutation detection systemOWD2023-06-27 View
PMA P120022 Somatic gene mutation detection systemOWD2021-07-07 View
PMA P190004 Somatic gene mutation detection systemOWD2019-05-24 View
510(k) K183597 QIAstat-Dx Respiratory PanelOCC2019-05-18 View
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