Company · DE
QIAGEN GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (3 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 |
| PSU | Jak2 Gene Mutation Detection Test | 2 |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 2 |
| JJH | Clinical Sample Concentrator | 1 |
| N/A | 1 | |
| OOI | Real Time Nucleic Acid Amplification System | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 1 |
| OWD | Somatic Gene Mutation Detection System | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 1 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 1 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K262168 | QIAstat-Dx BCID GN Plus AMR Panel QIAGEN GmbH, DE | PEN |
| Aug 6, 2026 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel QIAGEN GmbH, DE | PAM |
| Mar 9, 2026 | K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B QIAGEN GmbH, DE | PCH |
| Oct 22, 2025 | K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B QIAGEN GmbH, DE | PCH |
| Aug 27, 2025 | K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini QIAGEN GmbH, DE | QOF |
| Feb 28, 2025 | K250324 | QIAstat-Dx GI Panel 2 Mini B QIAGEN GmbH, DE | PCH |
| Jan 8, 2025 | K243813 | QIAstat-Dx GI Panel 2 Mini B&V QIAGEN GmbH, DE | PCH |
| Oct 29, 2024 | K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel QIAGEN GmbH, DE | PLO |
| Oct 25, 2024 | K242353 | QIAstat-Dx Respiratory Panel Mini QIAGEN GmbH, DE | QOF |
| May 31, 2024 | K220062 | QIAstat-Dx Gastrointestinal Panel 2 QIAGEN GmbH, DE | PCH |
| May 10, 2024 | K233100 | QIAstat-Dx® Respiratory Panel Plus QIAGEN GmbH, DE | QOF |
| May 18, 2019 | K183597 | QIAstat-Dx Respiratory Panel QIAGEN GmbH, DE | OCC |
| Jan 12, 2018 | K172287 | ipsogen JAK2 RGQ PCR Kit Qiagen, Inc. | PSU |
| Mar 27, 2017 | DEN160028 | ipsogen JAK2 RGQ PCR Kit Qiagen, Inc. | PSU |
| Dec 19, 2014 | K142738 | artus HSV-1/2 QS-RGQ MDx Kit Qiagen | OQO |
| Apr 4, 2014 | K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT QIAGEN GmbH | OZN |
| Feb 6, 2012 | K113323 | ARTUS INFL A/B RG RT-PCR KIT QIAGEN GmbH | OCC |
| Feb 6, 2012 | K113319 | ROTOR-GENE Q MDX QIAGEN GmbH | OOI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Qiagen GmbH therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene
REF 870021 (US IVD) Open, Classified |
OWD | None listed |
| Jul 27, 2023 | Qiagen GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.)
Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of resp Open, Classified |
QLT | None listed |
| Jul 27, 2023 | Qiagen GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or Open, Classified |
QLT | None listed |
| Jul 21, 2023 | Qiagen GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Open, Classified |
QJR | None listed |
| May 28, 2018 | QIAGEN EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Terminated |
JJH | None listed |
| Jul 22, 2017 | Qiagen, GmbH QIAamp DSP Virus Kit
Cat. No. 60704 Terminated |
N/A | None listed |