FDA Registration
Active
🇺🇸 United States
R723110 Liquid Stuarts,Single Swab PK/500
Reg #: 1924669
·
FEI: 1924669
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
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
- K943499
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 |
|---|---|---|---|---|---|
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2025-06-16 |
Proprietary Names
R723110 Liquid Stuarts,Single Swab PK/500
R723125 Liquid Stuarts,Dual Swab PK/50
R723130 Liquid Stuarts,Wire Shaft Swab PK/100
R723135 Liquid Stuarts,Wire Shaft PK/50
R723115 Liquid Stuarts,Single Swab PK/50
R723120 Liquid Stuarts,Dual Swab PK/500
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198