QIAGEN GmbH
Medical device manufacturer in Hilden, DE.
16510(k) clearances
11PMA approvals
6recalls
Device types
- PCH Gastrointestinal Pathogen Panel Multiplex… 5
- QOF Multi-Target Respiratory Specimen Nucleic… 3
- OCC Respiratory Virus Panel Nucleic Acid Assay… 2
- OOI Real Time Nucleic Acid Amplification System 1
- OZN C. Difficile Toxin Gene Amplification Assay 1
- OQO Herpes Simplex Virus Nucleic Acid… 1
- PSU Jak2 Gene Mutation Detection Test 1
- PLO Meningitis/Encephalitis Pathogen Multiplex… 1
- PAM Gram-Positive Bacteria And Their Resistance… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | 08/06/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | 03/09/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | 10/22/2025SE |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional | 08/27/2025SE |
| K250324 | QIAstat-Dx GI Panel 2 Mini BPCH · Special | 02/28/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | 01/08/2025SE |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO · Traditional | 10/29/2024SE |
| K242353 | QIAstat-Dx Respiratory Panel MiniQOF · Special | 10/25/2024SE |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2PCH · Traditional | 05/31/2024SE |
| K233100 | QIAstat-Dx® Respiratory Panel PlusQOF · Traditional | 05/10/2024SE |
| K183597 | QIAstat-Dx Respiratory PanelOCC · Traditional | 05/18/2019SE |
| K172287 | ipsogen JAK2 RGQ PCR KitPSU · Traditional | 01/12/2018SE |
| K142738 | artus HSV-1/2 QS-RGQ MDx KitOQO · Traditional | 12/19/2014SE |
| K133936 | Artus C. Difficile Qs-Rgq MDX KitOZN · Traditional | 04/04/2014SE |
| K113323 | Artus Infl A/B RG Rt-Pcr KitOCC · Traditional | 02/06/2012SE |
| K113319 | Rotor-Gene Q MDXOOI · Traditional | 02/06/2012SE |
PMA approvals
- P210002 therascreen PDGFRA RGQ PCR Kit · 06/29/2023 · 0 supplements
- P190026 therascreen BRAF V600E RGQ PCR Kit · 04/15/2020 · 1 supplement
- P190004 therascreen PIK3CA RGQ PCR Kit · 05/24/2019 · 0 supplements
- P190001 therascreen PIK3CA RGQ PCR Kit · 05/24/2019 · 2 supplements
- P180043 therascreen FGFR RGQ RT-PCR Kit · 04/12/2019 · 9 supplements
- P160052 PartoSure test · 04/11/2018 · 1 supplement
- P130027 Artus CMV RGQ MDX Kit · 06/02/2014 · 6 supplements
- P110027 Therascreen Kras RGQ PCR Kit · 05/23/2014 · 17 supplements
- P120022 Therascreen Egfr RGQ PCR Kit · 07/12/2013 · 20 supplements
- P010033 Quanttferon-Tb Gold and TB Gold-In-The-Tube · 11/28/2001 · 48 supplements
- P880009 Virapap Human Papillomavirus DNA Detection Kit · 12/23/1988 · 5 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2665-2023 Class II | therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx…Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag… | 08/22/2023Open, Classified |
| Z-2246-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the…Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since… | 05/19/2023Open, Classified |
| Z-2245-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing…Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since… | 05/19/2023Open, Classified |
| Z-2215-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and…If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and… | 05/09/2023Open, Classified |
| Z-2596-2018 Class II | EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.Underfilled reagent well that could lead to incorrect results | 05/28/2018Terminated |
| Z-0274-2018 Class II | QIAamp DSP Virus Kit Cat. No. 60704Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased… | 07/22/2017Terminated |