FDA Registration
Active
🇮🇹 Italy
MTS (MIC Test Strip) Delafloxacin 002-32 ?g/mL
Reg #: 3012389632
·
FEI: 3012389632
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LIOFILCHEM S.R.L.
- Registration Number
- 3012389632
- FEI Number
- 3012389632
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Scozia, Zona Industriale
- City
- Roseto degli Abruzzi Teramo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K171906
Owner / Operator
- Firm Name
- Liofilchem S.R.L.
- Operator Number
- 10052223
- Address
- Via Scozia, Zona Industriale
- City
- Roseto degli Abruzzi
- State
- Teramo
- Postal Code
- 64026
- Country
- IT
US Agent
- Business Name
- Laboratory Specialists, Inc.
- Contact Name
- Anthony DiFranco
- Address
- 26214 CENTER RIDGE RD
- City
- WESTLAKE
- State
- OH
- ZIP
- 44145
- Country
- US
- [email protected]
- Phone
- 440 5035887
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2017-08-01 |
Proprietary Names
MTS (MIC Test Strip) Delafloxacin 002-32 ?g/mL
Establishment Types
Manufacture Medical Device