FDA Registration
Active
🇺🇸 United States
QuantiFeron®-TB Gold Test
Reg #: 1122376
·
FEI: 3003572099
·
Expires 2025
Products
1
Proprietary Names
2
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
- PMA Number
- P010033
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 |
|---|---|---|---|---|---|
| Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | NCD | Class 3 | Unknown | No | 2015-05-28 |
Proprietary Names
QuantiFeron®-TB Gold Test
QuantiFeron®-TB Gold Plus Test
Establishment Types
Manufacture Medical Device