FDA Registration
Active
🇺🇸 United States
Sensititre AIM
Reg #: 1924669
·
FEI: 1924669
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- REMEL, INC.
- Registration Number
- 1924669
- FEI Number
- 1924669
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12076 Santa Fe Trail Dr
- City
- LENEXA
- State
- KS
- ZIP
- 66215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103456
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | Class 2 | Microbiology | No | 2014-08-18 |
| Reagent/Device, Inoculum Calibration | LIE | Class 2 | Microbiology | No | 2014-08-18 |
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2014-08-18 |
Proprietary Names
Sensititre AIM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility