FDA Registration
Active
🇺🇸 United States
Test System
Reg #: 1419968
·
FEI: 1419968
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BION ENTERPRISES, LTD.
- Registration Number
- 1419968
- FEI Number
- 1419968
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 455 State St Ste 100
- City
- DES PLAINES
- State
- IL
- ZIP
- 60016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K880679
Owner / Operator
- Firm Name
- BION ENTERPRISES, LTD.
- Operator Number
- 1419968
- Address
- 455 STATE STREET,, SUITE 100
- City
- Des Plaines
- State
- IL
- Postal Code
- 60016
- Country
- US
- Correspondent
- NADINE M SHABAT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigen, Cf (Including Cf Control), Cytomegalovirus | GQH | Class 2 | Microbiology | No | 2007-11-14 |
Proprietary Names
Test System
BION Cytomegalovirus, IgG
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device