FDA Registration
Active
🇺🇸 United States
PartoSure Test
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
- PMA Number
- P160052
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 |
|---|---|---|---|---|---|
| Placental Alpha Microglobulin-1 Immunoassay | QBB | Class 3 | Unknown | No | 2018-05-23 |
Proprietary Names
PartoSure Test
Establishment Types
Manufacture Medical Device