FDA Registration
Active
🇺🇸 United States
VITEK 2 AST-GP Pristinamycin
Reg #: 1950204
·
FEI: 1950204
·
Expires 2025
Products
1
Proprietary Names
32
Establishment Types
1
Classifications
1
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
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 | 2008-04-30 |
Proprietary Names
VITEK 2 AST-GP Pristinamycin
VITEK 2 AST-GP Quinupristin/ Dalfopristin
VITEK 2 AST-GP Mupirocin
VITEK 2 AST-GP Habekacin
VITEK 2 AST-GP Telithromycin
VITEK 2 AST-GP Pefloxacin
VITEK 2 AST-GP Amikacin
VITEK 2 AST-GP Fusidic Acid
VITEK 2 AST-GP Erythromycin
VITEK 2 AST-GP Rifampicin
VITEK 2 AST-GP Cefuroxime
VITEK 2 AST-GP Cefpodoxime
VITEK 2 AST-GP Flomoxef
VITEK 2 AST-GP Gatifloxacin
VITEK 2 AST-GP Imipenem
VITEK 2 AST-GP Amoxicillin/ Clavulanic Acid
VITEK 2 AST-GP Tobramycin
VITEK 2 AST-GP Kanamycin
VITEK 2 AST-GP Lincomycin
VITEK 2 AST-GP Amoxicillin
VITEK 2 AST-GP Ertapenem
VITEK 2 AST-GP Clarithromycin
VITEK 2 AST-GP Kanamycin High Level (synergy)
VITEK 2 AST-GP Gentamicin High-Level Resistance
VITEK 2 AST-GP Trimethoprim/ Sulfamethoxazole
VITEK 2 AST-GP Fosfomycin
VITEK 2 AST-GP Cefotaxime
VITEK 2 AST-GP Teicoplanin
VITEK 2 AST-GP Netilmicin
VITEK 2 AST-GP Cefmetazole
VITEK 2 AST-GP Trimethoprim
VITEK 2 AST-GP Cefalotin
Establishment Types
Manufacture Device in the United States for Export Only