FDA Registration
Active
🇺🇸 United States
IBT Scientific
Reg #: 3029754060
·
FEI: 3029754060
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- IBT Scientific
- Registration Number
- 3029754060
- FEI Number
- 3029754060
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1178 Telecom Drive
- City
- Creedmoor
- State
- NC
- ZIP
- 27522
- Country
- US
Regulatory Submissions
- 510(k) Number
- K953854
Owner / Operator
- Firm Name
- IBT Scientific LLC
- Operator Number
- 10083938
- Address
- 2931 Moose Trail
- City
- Elkhart
- State
- IN
- Postal Code
- 46514
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2024-09-29 |
| System, Dialysate Delivery, Single Patient | FKP | Class 2 | Gastroenterology, Urology | No | 2021-12-31 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2025-02-05 |
| Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | MSY | Class 2 | Gastroenterology, Urology | No | 2021-12-31 |
| Dialyzer Reprocessing System | LIF | Class 2 | Gastroenterology, Urology | No | 2021-12-31 |
Proprietary Names
WaterSoft Water Hardness Test
WaterSoft 0-30+ ppm Water Hardness Test
WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX
QwikCheck Chemical Indicator
Glutar Test 1; Forma Test
Peracid Test
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)