FDA Registration
Active
🇺🇸 United States
VITEK 2 AST-Gram Negative Ceftazidime
Reg #: 1950204
·
FEI: 1950204
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIOMERIEUX, INC.
- Registration Number
- 1950204
- FEI Number
- 1950204
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 595 ANGLUM RD.
- City
- HAZELWOOD
- State
- MO
- ZIP
- 63042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193299
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, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2020-10-15 |
| Susceptibility Test Cards, Antimicrobial | LTW | Class 2 | Microbiology | No | 2020-10-15 |
| Panels, Test, Susceptibility, Antimicrobial | LTT | Class 2 | Microbiology | No | 2020-10-15 |
Proprietary Names
VITEK 2 AST-Gram Negative Ceftazidime
Establishment Types
Manufacture Medical Device