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Sign in to claim this brandQIAGEN GmbH
Germany·DE-MF-000004949
Last updated May 24, 2026
What QIAGEN GmbH makes
QIAGEN GmbH manufactures instruments and kits for nucleic acid sample preparation and extraction, including automated systems like the Rotor-Gene Q MDx and EZ2 Connect MDx for molecular diagnostics, as well as manual extraction kits such as the RNeasy DSP MinElute Cleanup Kit. Their portfolio also includes specialized test components like the QFT-Plus reference lab packs, single-patient tubes, and dispenser packs for tuberculosis infection diagnostics, alongside the careBrush for sample collection. Additional products include the ipsogen RT Kit for genetic analysis and the QIAstat-Dx BCID GPF Plus AMR Panel for bacterial identification and antimicrobial resistance profiling.
The company’s devices are regulated under EU IVDR (Class A, C, I, II, III) and U.S. FDA pathways (510(k), PMA), with listings in the EUDAMED registry and FDA databases. QIAGEN GmbH is headquartered in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 1, QIAGEN Strasse, Hilden, Germany
- Website
- www.qiagen.com
- —
- —
- [email protected]
- Phone
- +492103290
- PRRC Contact
- Marcus Rembges
- EUDAMED SRN
- DE-MF-000004949
- FDA FEI Number
- —
- DUNS Number
- 317103745
Catalogue (55)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| therascreen EGFR RGQ PCR Kit | P120022 | FDA PMA | Class III | Active |
| Therascreen Kras Rgq Pcr Kit | P110027 | FDA PMA | Class III | Active |
| therascreen BRAF V600E RGQ PCR Kit | P190026 | FDA PMA | Class III | Active |
| therascreen FGFR RGQ RT-PCR Kit | P180043 | FDA PMA | Class III | Active |
| therascreen PIK3CA RGQ PCR Kit | P190004 | FDA PMA | Class III | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Qiagen, Inc. Germantown, MD · US FEI 3003572099