FDA Registration
Active
🇺🇸 United States
digene® HC2 DNA Collection Device
Reg #: 1122376
·
FEI: 3003572099
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QIAGEN
- Registration Number
- 1122376
- FEI Number
- 3003572099
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 19300 Germantown Rd
- City
- Germantown
- State
- MD
- ZIP
- 20874
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971586
Owner / Operator
- Firm Name
- QIAGEN Sciences LLC
- Operator Number
- 9002668
- Address
- 19300 Germantown Road, --
- City
- Germantown
- State
- MD
- Postal Code
- 20874
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2008-05-02 |
Proprietary Names
digene® HC2 DNA Collection Device
Establishment Types
Manufacture Medical Device