FDA Registration
Active
🇺🇸 United States
Obizur
Reg #: 3009340644
·
FEI: 3009340644
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHIRE HUMAN GENETIC THERAPIES, INC.
- Registration Number
- 3009340644
- FEI Number
- 3009340644
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 300 SHIRE WAY
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
Regulatory Submissions
- 510(k) Number
- K963583
Owner / Operator
- Firm Name
- Takeda Pharmaceuticals U.S.A, Inc.
- Operator Number
- 10051446
- Address
- 95 Hayden Avenue
- City
- Lexington
- State
- MA
- Postal Code
- 02421
- Country
- US
- Correspondent
- Shilpa Gampa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2020-12-18 |
Proprietary Names
Obizur
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility