Data / Medical devices / United Kingdom / QIAGEN Manchester Ltd
QIAGEN Manchester Ltd: FDA-registered device maker in Manchester Lancashire, United Kingdom, 1 510(k) clearance
QIAGEN Manchester Ltd is registered with the FDA (registration 3005118020) in Manchester Lancashire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005118020
- FEI number
- 3009391812
- Address
- CityLabs 2.0 200 Hathersage Road, Manchester Lancashire, United Kingdom, M13 0BH
- Owner or operator
- QIAGEN Manchester Ltd (10023024)
- Roles
- Specification developer
- First device listed
- December 14, 2017
- Registered through
- 2026
- Brand names listed
- EZ1 Advanced XL, QIAcube, QIAstat-Dx® Analyzer 1, QIAstat-Dx® Analyzer 2, QIAsymphony RGQ MDx, QIAsymphony SP, Rotor-Gene Q MDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Specification developer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 6, 2012 | K113319 | ROTOR-GENE Q MDX | OOI | Substantially Equivalent | QIAGEN GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 6, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.