FDA Registration
Active
🇺🇸 United States
BacT/ALERT SA (Plastic Bottles)
Reg #: 3002769706
·
FEI: 3002769706
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMERIEUX, INC.
- Registration Number
- 3002769706
- FEI Number
- 3002769706
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 RODOLPHE ST
- City
- DURHAM
- State
- NC
- ZIP
- 27712
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020931
Owner / Operator
- Firm Name
- BIOMERIEUX SA
- Operator Number
- 8020790
- Address
- Chemin De L Orme
- City
- Marcy L Etoile
- State
- Rhone
- Postal Code
- 69280
- Country
- FR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Blood Culturing | MDB | Class 1 | Microbiology | No | 2007-12-27 |
Proprietary Names
BacT/ALERT SA (Plastic Bottles)
Establishment Types
Manufacture Medical Device