FDA Registration
Active
🇺🇸 United States
ROMA (HE4 EIA + ARCHITECT CA 125 II)
Reg #: 2521625
·
FEI: 2521625
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fujirebio Diagnostics, Inc.
- Registration Number
- 2521625
- FEI Number
- 2521625
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103358
Owner / Operator
- Firm Name
- Fujirebio Diagnostics, Inc.
- Operator Number
- 10022860
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- Greg Dickson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ovarian Adnexal Mass Assessment Score Test System | ONX | Class 2 | Obstetrics/Gynecology | No | 2011-10-24 |
Proprietary Names
ROMA (HE4 EIA + ARCHITECT CA 125 II)
Establishment Types
Manufacture Medical Device