FDA Registration
Active
🇬🇧 United Kingdom
QIAsymphony RGQ MDx
Reg #: 3005118020
·
FEI: 3009391812
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QIAGEN Manchester Ltd
- Registration Number
- 3005118020
- FEI Number
- 3009391812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CityLabs 2.0, 200 Hathersage Road
- City
- Manchester Lancashire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K113319
Owner / Operator
- Firm Name
- QIAGEN Manchester Ltd
- Operator Number
- 10023024
- Address
- Citylabs 2.0, 200 Hathersage Road
- City
- Manchester
- State
- Lancashire
- Postal Code
- M13 0BH
- Country
- GB
US Agent
- Business Name
- QIAGEN
- Contact Name
- Kristen Kanack
- Address
- 19300 Germantown Rd
- City
- Germantown
- State
- MD
- ZIP
- 20874
- Country
- US
- [email protected]
- Phone
- 240 5060706
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2017-12-15 |
Proprietary Names
QIAsymphony RGQ MDx
Rotor-Gene Q MDx
QIAstat-Dx® Analyzer 1
QIAstat-Dx® Analyzer 2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility