FDA Registration
Active
🇺🇸 United States
MTS Doxycycline 016-256 ug/mL
Reg #: 3013661582
·
FEI: 3013661582
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Liofilchem, Inc.
- Registration Number
- 3013661582
- FEI Number
- 3013661582
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 465 Waverley Oaks Rd. Suite 317
- City
- Waltham
- State
- MA
- ZIP
- 02452
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190914
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2019-05-30 |
Proprietary Names
MTS Doxycycline 016-256 ug/mL
Establishment Types
Complaint File Establishment per 21 CFR 820.198