FDA Registration
Active
🇺🇸 United States
EAGLE BIOSCIENCES, INC.
Reg #: 3009014878
·
FEI: 3009014878
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- EAGLE BIOSCIENCES, INC.
- Registration Number
- 3009014878
- FEI Number
- 3009014878
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 20A NW Blvd, Suite 112
- City
- Nashua
- State
- NH
- ZIP
- 03063
- Country
- US
Owner / Operator
- Firm Name
- Eagle Biosciences, Inc.
- Operator Number
- 10077436
- Address
- 20A NW Blvd, Suite 112
- City
- Nashua
- State
- NH
- Postal Code
- 03063
- Country
- US
- Correspondent
- Daniel Keefe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2025-04-10 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-08-27 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-08-27 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-08-27 |
Proprietary Names
Pregnenolone ELISA
DIAGNOSTICS BIOCHEM CANADA, INC.
Biohit Healthcare (Hefei) Co. Ltd.
Healgen Scientific LLC
Jiangsu Bioperfectus Technologies Co., Ltd
Jiangsu Bioperfectus Technologies Co., Ltd.
Establishment Types
Complaint File Establishment per 21 CFR 820.198