FDA Registration
Active
🇩🇪 Germany
ipsogen® JAK2 RGQ PCR Kit
Reg #: 3004013603
·
FEI: 3004013603
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QIAGEN, GMBH
- Registration Number
- 3004013603
- FEI Number
- 3004013603
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- QIAGEN STRASSE 1
- City
- HILDEN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- DEN160028
Owner / Operator
- Firm Name
- QIAGEN, GmbH
- Operator Number
- 9065957
- Address
- QIAGEN STRASSE 1, --
- City
- HILDEN
- State
- DE-NOTA
- Postal Code
- 40724
- Country
- DE
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 |
|---|---|---|---|---|---|
| Jak2 Gene Mutation Detection Test | PSU | Class 2 | Medical Genetics | No | 2017-05-18 |
Proprietary Names
ipsogen® JAK2 RGQ PCR Kit
Establishment Types
Manufacture Medical Device